Trial Outcomes & Findings for Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism (NCT NCT00198107)
NCT ID: NCT00198107
Last Updated: 2019-04-09
Results Overview
The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscales is that higher scores, indicate greater severity. Fifteen item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total irritability scale store ranging from 0 to 45. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints. Confidence intervals reflect a Bonferroni multiple testing correction accounting
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
81 participants
Primary outcome timeframe
Weeks 1, 2, 3, 4, 6, and 8
Results posted on
2019-04-09
Participant Flow
Participant milestones
| Measure |
1 Placebo
Participants will take placebo
Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
|
2 Aripiprazole
Participants will take aripiprazole
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
|
3 Aripiprazole + D-cycloserine
Participants first will take aripiprazole then will also take D-cycloserine
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
|
|---|---|---|---|
|
Double-Blind Period
STARTED
|
41
|
40
|
0
|
|
Double-Blind Period
1 or More Follow-up Visits
|
40
|
38
|
0
|
|
Double-Blind Period
COMPLETED
|
35
|
37
|
0
|
|
Double-Blind Period
NOT COMPLETED
|
6
|
3
|
0
|
|
Pilot Add-On Aripiprazole +D-cycloserine
STARTED
|
0
|
0
|
10
|
|
Pilot Add-On Aripiprazole +D-cycloserine
COMPLETED
|
0
|
0
|
8
|
|
Pilot Add-On Aripiprazole +D-cycloserine
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
1 Placebo
Participants will take placebo
Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
|
2 Aripiprazole
Participants will take aripiprazole
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
|
3 Aripiprazole + D-cycloserine
Participants first will take aripiprazole then will also take D-cycloserine
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
|
|---|---|---|---|
|
Double-Blind Period
Adverse Event
|
1
|
1
|
0
|
|
Double-Blind Period
Lack of Efficacy
|
2
|
0
|
0
|
|
Double-Blind Period
Lost to Follow-up
|
2
|
1
|
0
|
|
Double-Blind Period
Physician Decision
|
1
|
0
|
0
|
|
Double-Blind Period
Withdrawal by Subject
|
0
|
1
|
0
|
|
Pilot Add-On Aripiprazole +D-cycloserine
Withdrawal by Subject
|
0
|
0
|
2
|
Baseline Characteristics
Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism
Baseline characteristics by cohort
| Measure |
1 Placebo
n=41 Participants
Participants will take placebo
Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
|
2 Aripiprazole
n=40 Participants
Participants will take aripiprazole
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
9.4 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
9.0 years
STANDARD_DEVIATION 2.9 • n=7 Participants
|
9.2 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 1, 2, 3, 4, 6, and 8Population: All randomized study participants with at least one post-baseline ABC score. One participant assigned to placebo and 2 participants assigned to aripiprazole had no post-baseline assessments.
The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscales is that higher scores, indicate greater severity. Fifteen item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total irritability scale store ranging from 0 to 45. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints. Confidence intervals reflect a Bonferroni multiple testing correction accounting
Outcome measures
| Measure |
1 Placebo
n=40 Participants
Participants will take placebo
Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
|
2 Aripiprazole
n=38 Participants
Participants will take aripiprazole
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
|
3 Aripiprazole + D-cycloserine
Participants first will take aripiprazole then will also take D-cycloserine
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
|
|---|---|---|---|
|
Mean Post-baseline Aberrant Behavior Checklist Irritability Score, Parent Report, Double-blind Phase
|
25.5 units on a scale
Interval 22.8 to 28.3
|
18.6 units on a scale
Interval 15.8 to 21.4
|
—
|
PRIMARY outcome
Timeframe: Weeks 1, 2, 3, 4, 6 and 8Population: All randomized study participants with at least one post-baseline CGI-I rating. One participant assigned to placebo and 2 participants assigned to aripiprazole had no post-baseline ratings.
Clinical Global Impressions (Guy, 1976) global improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7, with lower scores indicating greater improvement (1=very much improved and 2=much improved). Participants with a CGI-I score of 1 or 2 were classified as improved. Odds were estimated using a repeated measures logistic regression model with treatment group, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average log odds across study timepoints. Confidence intervals reflect a Bonferroni multiple testing correction accounting for the selection of two primary outcomes.
Outcome measures
| Measure |
1 Placebo
n=40 Participants
Participants will take placebo
Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
|
2 Aripiprazole
n=38 Participants
Participants will take aripiprazole
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
|
3 Aripiprazole + D-cycloserine
Participants first will take aripiprazole then will also take D-cycloserine
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
|
|---|---|---|---|
|
Odds of Improvement as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2)
|
0.10 odds
Interval 0.05 to 0.23
|
0.50 odds
Interval 0.31 to 0.79
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 6 and 8Population: All randomized study participants with at least one post-baseline ABC score. One participant assigned to placebo and 2 participants assigned to aripiprazole had no post-baseline assessments.
The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers overactivity, impulsiveness, inattention and noncompliance. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscale is that higher scores, indicate greater severity. Sixteen item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total score ranging from 0 to 48. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints.
Outcome measures
| Measure |
1 Placebo
n=40 Participants
Participants will take placebo
Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
|
2 Aripiprazole
n=38 Participants
Participants will take aripiprazole
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
|
3 Aripiprazole + D-cycloserine
Participants first will take aripiprazole then will also take D-cycloserine
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
|
|---|---|---|---|
|
Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Score, Parent Report, Double-blind Phase
|
29.7 units on a scale
Interval 26.8 to 32.5
|
22.5 units on a scale
Interval 19.6 to 25.4
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 6, and 8Population: All randomized study participants with at least one post-baseline ABC score. One participant assigned to placebo and 2 participants assigned to aripiprazole had no post-baseline assessments.
The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscales is that higher scores, indicate greater severity. Four item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total inappropriate speech scale score ranging from 0 to 12. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints.
Outcome measures
| Measure |
1 Placebo
n=40 Participants
Participants will take placebo
Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
|
2 Aripiprazole
n=38 Participants
Participants will take aripiprazole
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
|
3 Aripiprazole + D-cycloserine
Participants first will take aripiprazole then will also take D-cycloserine
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
|
|---|---|---|---|
|
Mean Post-baseline Aberrant Behavior Checklist Inappropriate Speech Score, Parent Report, Double-blind Phase
|
7.4 units on a scale
Interval 6.7 to 8.1
|
5.0 units on a scale
Interval 4.2 to 5.7
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 6, and 8Population: All randomized study participants with at least one post-baseline ABC score. One participant assigned to placebo and 2 participants assigned to aripiprazole had no post-baseline assessments.
The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscales is that higher scores, indicates greater severity. Sixteen item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total social withdrawal scale score ranging from 0 to 48. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints.
Outcome measures
| Measure |
1 Placebo
n=40 Participants
Participants will take placebo
Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
|
2 Aripiprazole
n=38 Participants
Participants will take aripiprazole
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
|
3 Aripiprazole + D-cycloserine
Participants first will take aripiprazole then will also take D-cycloserine
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
|
|---|---|---|---|
|
Mean Post-baseline Aberrant Behavior Checklist Social Withdrawal Score, Parent Report, Double-blind Phase
|
15.4 units on a scale
Interval 13.4 to 17.5
|
11.7 units on a scale
Interval 9.6 to 13.7
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 6, and 8Population: All randomized study participants with at least one post-baseline ABC score. One participant assigned to placebo and 2 participants assigned to aripiprazole had no post-baseline assessments.
The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its subscales is that higher scores, indicates greater severity. Seven item scores with values ranging from 0 (not a problem) to 3 (problem is severe) are summed to arrive at the total stereotypy scale score ranging from 0 to 21. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints.
Outcome measures
| Measure |
1 Placebo
n=40 Participants
Participants will take placebo
Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
|
2 Aripiprazole
n=38 Participants
Participants will take aripiprazole
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
|
3 Aripiprazole + D-cycloserine
Participants first will take aripiprazole then will also take D-cycloserine
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
|
|---|---|---|---|
|
Mean Post-baseline Aberrant Behavior Checklist Stereotypy Score, Parent Report, Double-blind Phase
|
10.0 units on a scale
Interval 8.9 to 11.1
|
7.2 units on a scale
Interval 6.0 to 8.3
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6 and 8Population: All randomized study participants with at least one post-baseline CY-BOCS score. Two participants assigned to placebo and 2 participants assigned to aripiprazole had no post-baseline assessments.
The CYBOCS- PDD is a semi-structured clinician-rated scale designed to rate the current severity of repetitive behavior in children with idiopathic autism spectrum disorders. Once the current repetitive behaviors are identified, they are rated on: Time Spent, Interference, Distress, Resistance, and Control. Each of these items is scored from 0 (least symptomatic) to 4 (most symptomatic), yielding a Total score from 0 to 20. Higher scores indicate higher severity. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and sex x Tanner stage stratum as covariates. A linear contrast estimated the average across study timepoints.
Outcome measures
| Measure |
1 Placebo
n=39 Participants
Participants will take placebo
Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
|
2 Aripiprazole
n=38 Participants
Participants will take aripiprazole
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
|
3 Aripiprazole + D-cycloserine
Participants first will take aripiprazole then will also take D-cycloserine
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
|
|---|---|---|---|
|
Mean Post-baseline Score on a Modified Version of the Compulsion Subscale of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
|
14.4 units on a scale
Interval 13.4 to 15.5
|
12.5 units on a scale
Interval 11.5 to 13.5
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized study participants. For 7 participants who exited the double-blind phase prior to week 8 but completed an exit interview (all assigned to placebo), week 8 scores were imputed using a last observation carried forward approach.
The Vineland Adaptive Behavior Scales, (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. An increase in standard scores from Baseline to the Final Visit indicates improvement. Means were estimated using a repeated measures linear regression model with treatment group, study week (in categories, baseline or 8 weeks), and sex x Tanner stage stratum as covariates.
Outcome measures
| Measure |
1 Placebo
n=41 Participants
Participants will take placebo
Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
|
2 Aripiprazole
n=40 Participants
Participants will take aripiprazole
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
|
3 Aripiprazole + D-cycloserine
Participants first will take aripiprazole then will also take D-cycloserine
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
|
|---|---|---|---|
|
Mean Vineland Maladaptive Behavior Subscales Total Score, Week 8
|
33.1 units on a scale
Interval 29.6 to 36.6
|
23.1 units on a scale
Interval 19.6 to 26.5
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized study participants. For 9 participants who exited the double-blind phase prior to week 8 but completed an exit interview (8 assigned to placebo and 1 to aripiprazole), week 8 scores were imputed using a last observation carried forward approach.
Autism Diagnostic Observation Scale (ADOS) (Lord), Modules 1-3 yields scores in 2 scales: Social Affect and Restricted and Repetitive Behavior. The ADOS has been repeatedly evaluated as a diagnostic measure, it has also been used as an outcome measure of autism severity (Aldred et al., 2004; Gutstein, 2007; Owly et al, 2001, Green et al, 2010). For modules 1-3, scores ranging from 0-2 on 14 items are summed to arrive at the Social Affect and Restricted and Repetitive Behavior Total Score, which ranges from 0 to 28. Higher scores indicate greater autism severity. Means were estimated using a repeated measures linear regression model with treatment group, study week (in categories, baseline or 8 weeks), and sex x Tanner stage stratum as covariates
Outcome measures
| Measure |
1 Placebo
n=41 Participants
Participants will take placebo
Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
|
2 Aripiprazole
n=40 Participants
Participants will take aripiprazole
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
|
3 Aripiprazole + D-cycloserine
Participants first will take aripiprazole then will also take D-cycloserine
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
|
|---|---|---|---|
|
Mean Autism Diagnostic Observation Schedule (ADOS) Social Affect and Restricted and Repetitive Behaviors Total Score, Week 8
|
19.0 units on a scale
Interval 17.6 to 20.4
|
18.3 units on a scale
Interval 17.0 to 19.7
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized study participants. For 9 participants who exited the double-blind phase prior to week 8 but completed an exit interview (8 assigned to placebo and 1 to aripiprazole), week 8 scores were imputed using a last observation carried forward approach.
The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total score results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment. Means were estimated using a repeated measures linear regression model with treatment group, study week (in categories, baseline or 8 weeks), and sex x Tanner stage stratum as covariates.
Outcome measures
| Measure |
1 Placebo
n=41 Participants
Participants will take placebo
Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
|
2 Aripiprazole
n=40 Participants
Participants will take aripiprazole
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
|
3 Aripiprazole + D-cycloserine
Participants first will take aripiprazole then will also take D-cycloserine
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
|
|---|---|---|---|
|
Mean Social Reciprocity Scale (SRS) Total Score, Week 8
|
127.6 units on a scale
Interval 119.8 to 135.3
|
112.6 units on a scale
Interval 104.8 to 120.3
|
—
|
Adverse Events
1 Placebo
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
2 Aripiprazole
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
3 Aripiprazole + D-cycloserine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1 Placebo
n=40 participants at risk
Participants will take placebo
Placebo: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
|
2 Aripiprazole
n=40 participants at risk
Participants will take aripiprazole
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
|
3 Aripiprazole + D-cycloserine
n=10 participants at risk
Participants first will take aripiprazole then will also take D-cycloserine
Aripiprazole: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
D-cycloserine: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
|
|---|---|---|---|
|
Gastrointestinal disorders
Change in Stool
|
5.0%
2/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
5.0%
2/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
4/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
20.0%
8/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
17.5%
7/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
50.0%
5/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
5.0%
2/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Gastrointestinal disorders
Stomach or abdominal discomfort
|
10.0%
4/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
17.5%
7/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
20.0%
2/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
8/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
37.5%
15/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
30.0%
3/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
General disorders
Dry mouth
|
5.0%
2/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
5.0%
2/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
General disorders
Hypersalivation
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
10.0%
1/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
General disorders
Appetite decrease
|
15.0%
6/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
30.0%
12/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
10.0%
1/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
General disorders
Appetite increase
|
27.5%
11/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
40.0%
16/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
30.0%
3/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
General disorders
Sedation/Drowsiness
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
12.5%
5/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
General disorders
Tiredness/fatigue
|
25.0%
10/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
52.5%
21/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
20.0%
2/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
General disorders
Fever
|
5.0%
2/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Infections and infestations
Flu or upper respiratory problems
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
10.0%
1/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Infections and infestations
Nasal congestion or Cold
|
40.0%
16/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
40.0%
16/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
10.0%
1/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Metabolism and nutrition disorders
Weight gain
|
12.5%
5/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
20.0%
8/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Metabolism and nutrition disorders
Weight loss
|
12.5%
5/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
10.0%
4/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
10.0%
1/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Nervous system disorders
Headache
|
20.0%
8/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
10.0%
1/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Nervous system disorders
Muscle rigidity
|
0.00%
0/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Nervous system disorders
Tremor
|
0.00%
0/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Psychiatric disorders
Anxiety/Nervousness/Worry
|
0.00%
0/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
10.0%
1/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Psychiatric disorders
Change in speech
|
17.5%
7/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
20.0%
2/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Psychiatric disorders
Difficulty falling asleep
|
15.0%
6/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Psychiatric disorders
Increased motor activity
|
12.5%
5/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
20.0%
2/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Psychiatric disorders
Increased repetitive speech
|
5.0%
2/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
10.0%
1/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Psychiatric disorders
Interrupted sleep/other sleep problems
|
20.0%
8/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
10.0%
4/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
10.0%
1/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Psychiatric disorders
Irritability
|
17.5%
7/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
20.0%
2/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Psychiatric disorders
Restlessness/Agitation, including fidgety
|
5.0%
2/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
20.0%
2/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Psychiatric disorders
Sadness
|
0.00%
0/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Psychiatric disorders
Self-Injurious Behavior
|
2.5%
1/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Psychiatric disorders
Stereotypy
|
20.0%
8/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
20.0%
2/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Renal and urinary disorders
Enuresis
|
5.0%
2/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
4/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
20.0%
2/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Skin and subcutaneous tissue disorders
Localized rash
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Vascular disorders
Dizziness/faintness
|
0.00%
0/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
10.0%
4/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
10.0%
1/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Vascular disorders
Intermittent nosebleed
|
0.00%
0/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
7.5%
3/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
|
Psychiatric disorders
Hypertalkativeness
|
0.00%
0/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
0.00%
0/40 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
10.0%
1/10 • Eight weeks or at the time of latest data collection.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place