Trial Outcomes & Findings for Comparison of Aripiprazole and Risperidone for the Treatment of People With First-Episode Psychosis (NCT NCT00320671)
NCT ID: NCT00320671
Last Updated: 2016-09-08
Results Overview
Brief Psychiatric Rating Scale-Anchored (BPRS-A) 4 items on this scale were examined to determine subjects responder status: Items 4. Conceptual Disorganization 8. Grandiosity 12. Hallucinations and 15. Unusual Thought Content. Scores range from-7 (not assessed) to 7 (very severe) Subjects with scores of 3 or less on all 4 items for 2 consecutive visits are deemed responders, subjects with 4 or greater and any of the aforementioned items for 2 consecutive study visits are non responders. Additionally, the subjects response on the Clinical Global Impressions Scale. A Clinical Global Improvement CGI) rating of much or very much improved on 2 consecutive ratings were deemed a responder. Percentages and confidence intervals were used to report response outcome. Response status was assessed throughout the duration of the study; a participant can be deemed a responder any time between weeks 1-week 12. The possible range for this outcome is a score of 4 to 28
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
198 participants
Primary outcome timeframe
this outcome was assessed throughout the study.
Results posted on
2016-09-08
Participant Flow
Participant milestones
| Measure |
Participants Will Take Aripiprazole Arm 1
-102 were allocated to Arm 1.
|
Participants Will Take Risperidone Arm 2
-96 participants were randomized to to Arm 2
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
96
|
|
Overall Study
COMPLETED
|
69
|
58
|
|
Overall Study
NOT COMPLETED
|
33
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Aripiprazole and Risperidone for the Treatment of People With First-Episode Psychosis
Baseline characteristics by cohort
| Measure |
Participants Will Take Aripiprazole
n=102 Participants
Participants will take aripiprazole
Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
|
Participants Will Take Risperidone
n=96 Participants
Participants will take risperidone
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
28 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
142 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
143 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African-American
|
38 participants
n=93 Participants
|
35 participants
n=4 Participants
|
73 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
22 participants
n=93 Participants
|
17 participants
n=4 Participants
|
39 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
21 participants
n=93 Participants
|
27 participants
n=4 Participants
|
48 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
11 participants
n=93 Participants
|
9 participants
n=4 Participants
|
20 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed
|
9 participants
n=93 Participants
|
7 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=93 Participants
|
96 participants
n=4 Participants
|
198 participants
n=27 Participants
|
|
Structured Clinical Interview for DSM-IV Axis I Disorders
psychosis NOS
|
6 participants
n=93 Participants
|
11 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
Structured Clinical Interview for DSM-IV Axis I Disorders
Schizoaffective Disorder
|
2 participants
n=93 Participants
|
4 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Structured Clinical Interview for DSM-IV Axis I Disorders
Schizophrenia
|
72 participants
n=93 Participants
|
59 participants
n=4 Participants
|
131 participants
n=27 Participants
|
|
Structured Clinical Interview for DSM-IV Axis I Disorders
Schizophreniform Disorder
|
22 participants
n=93 Participants
|
22 participants
n=4 Participants
|
44 participants
n=27 Participants
|
|
BPRS-A
|
14.66 units on a scale
n=93 Participants
|
14.42 units on a scale
n=4 Participants
|
14.54 units on a scale
n=27 Participants
|
|
Scale for the Assessment of Negative
Affective flattening
|
1.85 units on a scale
STANDARD_DEVIATION 0.09 • n=93 Participants
|
1.74 units on a scale
STANDARD_DEVIATION .09 • n=4 Participants
|
1.795 units on a scale
STANDARD_DEVIATION .09 • n=27 Participants
|
|
Scale for the Assessment of Negative
Alogia
|
2.08 units on a scale
STANDARD_DEVIATION .08 • n=93 Participants
|
1.96 units on a scale
STANDARD_DEVIATION .09 • n=4 Participants
|
2.02 units on a scale
STANDARD_DEVIATION .85 • n=27 Participants
|
|
Scale for the Assessment of Negative
avolition-apathy
|
2.16 units on a scale
STANDARD_DEVIATION .10 • n=93 Participants
|
2.02 units on a scale
STANDARD_DEVIATION .10 • n=4 Participants
|
2.09 units on a scale
STANDARD_DEVIATION .10 • n=27 Participants
|
|
Scale for the Assessment of Negative
asociality-anhedonia
|
2.19 units on a scale
STANDARD_DEVIATION .08 • n=93 Participants
|
2.07 units on a scale
STANDARD_DEVIATION .09 • n=4 Participants
|
2.12 units on a scale
STANDARD_DEVIATION .85 • n=27 Participants
|
|
Metabolic Outcomes
Total Cholesterol Baseline
|
158.25 mg/dl
STANDARD_DEVIATION 3.15 • n=93 Participants
|
157.01 mg/dl
STANDARD_DEVIATION 3.30 • n=4 Participants
|
157.63 mg/dl
STANDARD_DEVIATION 3.225 • n=27 Participants
|
|
Metabolic Outcomes
LDL cholesterol Baseline
|
86.37 mg/dl
STANDARD_DEVIATION 2.60 • n=93 Participants
|
88.25 mg/dl
STANDARD_DEVIATION 2.77 • n=4 Participants
|
87.31 mg/dl
STANDARD_DEVIATION 2.685 • n=27 Participants
|
|
Metabolic Outcomes
HDL Cholesterol baseline
|
55.99 mg/dl
STANDARD_DEVIATION 1.37 • n=93 Participants
|
53.23 mg/dl
STANDARD_DEVIATION 1.40 • n=4 Participants
|
54.61 mg/dl
STANDARD_DEVIATION 1.385 • n=27 Participants
|
|
Metabolic Outcomes
Triglycerides baseline
|
80.00 mg/dl
STANDARD_DEVIATION 4.48 • n=93 Participants
|
77.41 mg/dl
STANDARD_DEVIATION 4.50 • n=4 Participants
|
78.705 mg/dl
STANDARD_DEVIATION 4.49 • n=27 Participants
|
|
Metabolic Outcomes
Fasting glucose baseline
|
85.06 mg/dl
STANDARD_DEVIATION 0.69 • n=93 Participants
|
84.60 mg/dl
STANDARD_DEVIATION 0.89 • n=4 Participants
|
84.83 mg/dl
STANDARD_DEVIATION .79 • n=27 Participants
|
|
hollingshead- index of social position
Highest Educational Level
|
4.0 units on a scale
STANDARD_DEVIATION 1.4 • n=93 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 1.1 • n=4 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 1.2 • n=27 Participants
|
|
hollingshead- index of social position
Social Class for subject
|
4.2 units on a scale
STANDARD_DEVIATION .8 • n=93 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 3.4 • n=4 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 2.5 • n=27 Participants
|
|
hollingshead- index of social position
social class for parent
|
3.3 units on a scale
STANDARD_DEVIATION 1.3 • n=93 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 3.6 • n=4 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 2.7 • n=27 Participants
|
|
Marital Status
Never Married
|
92 participants
n=93 Participants
|
90 participants
n=4 Participants
|
182 participants
n=27 Participants
|
|
Marital Status
Married
|
1 participants
n=93 Participants
|
3 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Marital Status
Remarried
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Marital Status
Divorced
|
6 participants
n=93 Participants
|
3 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Marital Status
Unknown
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Fasting insulin
|
12.39 uU/ml
STANDARD_DEVIATION 1.10 • n=93 Participants
|
13.10 uU/ml
STANDARD_DEVIATION 1.38 • n=4 Participants
|
12.745 uU/ml
STANDARD_DEVIATION 1.24 • n=27 Participants
|
|
Prolactin Level Female
|
61.84 ng/ml
STANDARD_DEVIATION 7.61 • n=93 Participants
|
65.52 ng/ml
STANDARD_DEVIATION 12.88 • n=4 Participants
|
63.68 ng/ml
STANDARD_DEVIATION 10.24 • n=27 Participants
|
|
Prolactin Level Male
|
28.72 ng/ml
STANDARD_DEVIATION 3.05 • n=93 Participants
|
31.50 ng/ml
STANDARD_DEVIATION 3.24 • n=4 Participants
|
30.11 ng/ml
STANDARD_DEVIATION 3.145 • n=27 Participants
|
PRIMARY outcome
Timeframe: this outcome was assessed throughout the study.Population: BPRS-A and CGI scores for each group were analysed to determine the percentage of participants that responded to apriprazole and risperidone. The threshold for significance was p=.05
Brief Psychiatric Rating Scale-Anchored (BPRS-A) 4 items on this scale were examined to determine subjects responder status: Items 4. Conceptual Disorganization 8. Grandiosity 12. Hallucinations and 15. Unusual Thought Content. Scores range from-7 (not assessed) to 7 (very severe) Subjects with scores of 3 or less on all 4 items for 2 consecutive visits are deemed responders, subjects with 4 or greater and any of the aforementioned items for 2 consecutive study visits are non responders. Additionally, the subjects response on the Clinical Global Impressions Scale. A Clinical Global Improvement CGI) rating of much or very much improved on 2 consecutive ratings were deemed a responder. Percentages and confidence intervals were used to report response outcome. Response status was assessed throughout the duration of the study; a participant can be deemed a responder any time between weeks 1-week 12. The possible range for this outcome is a score of 4 to 28
Outcome measures
| Measure |
Percentage of Participants That Reposonded to Aripiprazole
n=102 Participants
Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
|
Percentage of Participants That Reposonded to Risperidone
n=96 Participants
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
|
|---|---|---|
|
Percentage of Participants That Responded to Treatment
|
62.8 percentage of response
Interval 50.8 to 74.8
|
56.8 percentage of response
Interval 43.9 to 69.9
|
Adverse Events
Participants Will Take Aripiprazole
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants Will Take Risperidone
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants Will Take Aripiprazole
n=102 participants at risk
Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
|
Participants Will Take Risperidone
n=96 participants at risk
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
|
|---|---|---|
|
Psychiatric disorders
hospitalization
|
6.9%
7/102 • Number of events 7 • Adverse events were assessed throughout the duration of the study., up to 12 weeks. The only serious adverse event that was reported was subjects being admitted to the hospital. No other serious adverse occurred throughout the duration of the study.
|
12.5%
12/96 • Number of events 12 • Adverse events were assessed throughout the duration of the study., up to 12 weeks. The only serious adverse event that was reported was subjects being admitted to the hospital. No other serious adverse occurred throughout the duration of the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place