Trial Outcomes & Findings for Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder (NCT NCT00194012)
NCT ID: NCT00194012
Last Updated: 2017-06-26
Results Overview
The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.
COMPLETED
PHASE3
62 participants
Baseline
2017-06-26
Participant Flow
Patients were recruited beginning 8/2004 with follow up interviews completed 5/2012. Families were recruited from an outpatient child/adolescent psychiatric research center and an adult mood disorders program at University Hospitals, Case Medical Center.
After screening and baseline assessments study participants were assigned to aripiprazole or placebo. Treatment was initiated at a dose of 0.1mg/kg/d. The dose could be increased by approximately 0.05 mg/kg/d at each study visit if patient experienced residual symptomology with no intolerable side effect to maximum dose 15mg/d.
Participant milestones
| Measure |
Aripiprazole
Abilify (aripiprazole): Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo
placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
Randomized Phase
STARTED
|
31
|
31
|
|
Randomized Phase
Received More Than One Dose
|
30
|
29
|
|
Randomized Phase
COMPLETED
|
15
|
6
|
|
Randomized Phase
NOT COMPLETED
|
16
|
25
|
|
Open Label Extension (OLE)
STARTED
|
22
|
21
|
|
Open Label Extension (OLE)
COMPLETED
|
17
|
15
|
|
Open Label Extension (OLE)
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Aripiprazole
Abilify (aripiprazole): Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo
placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
Randomized Phase
Lack of Efficacy
|
8
|
18
|
|
Randomized Phase
Study nonadherence
|
2
|
1
|
|
Randomized Phase
Withdrawal by Subject
|
3
|
3
|
|
Randomized Phase
Adverse Event
|
2
|
1
|
|
Randomized Phase
Participant reported having a rash
|
1
|
0
|
|
Randomized Phase
Emesis and enuresis
|
0
|
1
|
|
Randomized Phase
Oral/nasal twitching
|
0
|
1
|
|
Open Label Extension (OLE)
Weight Gain
|
1
|
0
|
|
Open Label Extension (OLE)
Drowsiness; Jittery
|
0
|
1
|
|
Open Label Extension (OLE)
Lost to Follow-up
|
3
|
5
|
|
Open Label Extension (OLE)
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Abilify Randomized Phase
n=30 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=29 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 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
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineThe Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.
Outcome measures
| Measure |
Abilify Randomized Phase
n=30 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=29 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
Young Mania Rating Scale (YMRS)
|
24.8 Scores on a scale
Standard Deviation 6.8
|
21.6 Scores on a scale
Standard Deviation 6.1
|
PRIMARY outcome
Timeframe: 12 weeksThe Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.
Outcome measures
| Measure |
Abilify Randomized Phase
n=30 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=29 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
Young Mania Rating Scale (YMRS)
|
9.7 Scores on a scale
Standard Deviation 9.2
|
16.2 Scores on a scale
Standard Deviation 8.5
|
PRIMARY outcome
Timeframe: Open-Label Extension - 6 weeksPopulation: 22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 18 of those 21 completed the YMRS and were available and included the analysis.
The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.
Outcome measures
| Measure |
Abilify Randomized Phase
n=20 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=18 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
Young Mania Rating Scale (YMRS)
|
5.73 Scores on a scale
Standard Deviation 5.98
|
7.57 Scores on a scale
Standard Deviation 5.12
|
SECONDARY outcome
Timeframe: BaselinePopulation: There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.
The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms.
Outcome measures
| Measure |
Abilify Randomized Phase
n=28 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=28 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
Children's Depression Rating Scale-Revised (CDRS-R )
|
33.7 Scores on a scale
Standard Deviation 11.2
|
30.3 Scores on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.
The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms.
Outcome measures
| Measure |
Abilify Randomized Phase
n=28 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=28 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
CDRS-R Children's Depression Rating Scale-Revised
|
24.4 Scores on a scale
Standard Deviation 7.5
|
25.9 Scores on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Open-Label Extension - 6 weeksPopulation: 22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 18 of those 21 completed the CDRS-R and were available and included the analysis.
The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms.
Outcome measures
| Measure |
Abilify Randomized Phase
n=20 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=18 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
CDRS-R Children's Depression Rating Scale-Revised
|
21.5 Scores on a scale
Standard Deviation 5.48
|
21.7 Scores on a scale
Standard Deviation 5.54
|
SECONDARY outcome
Timeframe: BaselinePopulation: There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.
Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 "Doing very well" to 1-10 Extremely impaired. The score should be calculated separate from diagnosis, treatment or prognosis.
Outcome measures
| Measure |
Abilify Randomized Phase
n=28 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=28 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
Children's Global Assessment Scale (CGAS)
|
56.1 Scores on a scale
Standard Deviation 6.7
|
57.5 Scores on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.
Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 "Doing very well" to 1-10 Extremely impaired. The score should be calculated separate from diagnosis, treatment or prognosis.
Outcome measures
| Measure |
Abilify Randomized Phase
n=28 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=28 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
Children's Global Assessment Scale (CGAS)
|
67.1 Scores on a scale
Standard Deviation 11.2
|
61.4 Scores on a scale
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Open-Label Extension - 6 weeksPopulation: 22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 19 of those 22 and 18 of those 21 completed the CGAS and were available and included the analysis.
Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 "Doing very well" to 1-10 Extremely impaired. The score should be calculated separate from diagnosis, treatment or prognosis.
Outcome measures
| Measure |
Abilify Randomized Phase
n=19 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=18 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
Children's Global Assessment Scale (CGAS)
|
71.47 Scores on a scale
Standard Deviation 8.49
|
69.72 Scores on a scale
Standard Deviation 6.47
|
SECONDARY outcome
Timeframe: BaselinePopulation: There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.
Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Abilify Randomized Phase
n=28 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=28 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
Clinical Global Impressions Scale (CGI-Severity)
|
4.2 units on a scale
Standard Deviation 0.9
|
3.8 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.
Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Abilify Randomized Phase
n=28 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=28 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
Clinical Global Impressions Scale (CGI-Severity)
|
2.3 units on a scale
Standard Deviation 1.4
|
3.0 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Open-Label Extension - 6 weeksPopulation: 22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 18 of those 21 completed the CGI-S and were available and included the analysis.
Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Abilify Randomized Phase
n=20 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=18 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
Clinical Global Impressions Scale (CGI-Severity)
|
1.85 Scores on a scale
Standard Deviation .875
|
1.89 Scores on a scale
Standard Deviation .758
|
SECONDARY outcome
Timeframe: BaselinePopulation: There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.
The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54.
Outcome measures
| Measure |
Abilify Randomized Phase
n=28 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=28 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)
|
32.4 units on a scale
Standard Deviation 12.4
|
36.8 units on a scale
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis.
The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54.
Outcome measures
| Measure |
Abilify Randomized Phase
n=28 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=28 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)
|
21.0 units on a scale
Standard Deviation 14.5
|
32.1 units on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Open-Label Extension - 6 weeksPopulation: 22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 17 of those 21 completed the ARS-IV and were available and included the analysis.
The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54.
Outcome measures
| Measure |
Abilify Randomized Phase
n=20 Participants
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=17 Participants
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
|---|---|---|
|
Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)
|
18.1 Scores on a scale
Standard Deviation 14.0
|
28.1 Scores on a scale
Standard Deviation 12.8
|
Adverse Events
Abilify Randomized Phase
Placebo Randomized Phase
Open Label Extension (Abilify)
Open Label Extension (Placebo)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Abilify Randomized Phase
n=31 participants at risk
Abilify (aripiprazole): Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
|
Placebo Randomized Phase
n=31 participants at risk
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
|
Open Label Extension (Abilify)
n=22 participants at risk
Previously randomized to Abilify group.
|
Open Label Extension (Placebo)
n=21 participants at risk
Previously randomized to placebo group.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
48.4%
15/31
|
38.7%
12/31
|
36.4%
8/22
|
23.8%
5/21
|
|
Gastrointestinal disorders
Stomach ache
|
35.5%
11/31
|
22.6%
7/31
|
13.6%
3/22
|
28.6%
6/21
|
|
General disorders
Sedation
|
22.6%
7/31
|
6.5%
2/31
|
4.5%
1/22
|
19.0%
4/21
|
|
General disorders
Increased appetite
|
22.6%
7/31
|
3.2%
1/31
|
36.4%
8/22
|
4.8%
1/21
|
|
Gastrointestinal disorders
Emesis
|
22.6%
7/31
|
0.00%
0/31
|
27.3%
6/22
|
4.8%
1/21
|
|
Gastrointestinal disorders
Nausea
|
16.1%
5/31
|
6.5%
2/31
|
0.00%
0/22
|
9.5%
2/21
|
|
Gastrointestinal disorders
Diarrhea
|
12.9%
4/31
|
6.5%
2/31
|
4.5%
1/22
|
0.00%
0/21
|
|
General disorders
Fever
|
12.9%
4/31
|
3.2%
1/31
|
0.00%
0/22
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
16.1%
5/31
|
6.5%
2/31
|
18.2%
4/22
|
4.8%
1/21
|
|
General disorders
Dizziness
|
12.9%
4/31
|
6.5%
2/31
|
0.00%
0/22
|
4.8%
1/21
|
|
General disorders
Nasal Congestion
|
9.7%
3/31
|
3.2%
1/31
|
4.5%
1/22
|
0.00%
0/21
|
|
General disorders
Coughing
|
12.9%
4/31
|
0.00%
0/31
|
9.1%
2/22
|
0.00%
0/21
|
|
General disorders
Sore Throat
|
6.5%
2/31
|
3.2%
1/31
|
4.5%
1/22
|
0.00%
0/21
|
|
General disorders
Cold Symptoms
|
6.5%
2/31
|
3.2%
1/31
|
13.6%
3/22
|
0.00%
0/21
|
|
General disorders
Weight Gain
|
0.00%
0/31
|
0.00%
0/31
|
13.6%
3/22
|
9.5%
2/21
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/31
|
0.00%
0/31
|
4.5%
1/22
|
14.3%
3/21
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/31
|
0.00%
0/31
|
13.6%
3/22
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Injury
|
0.00%
0/31
|
0.00%
0/31
|
27.3%
6/22
|
9.5%
2/21
|
|
Skin and subcutaneous tissue disorders
Athletes Foot
|
0.00%
0/31
|
0.00%
0/31
|
4.5%
1/22
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/22
|
19.0%
4/21
|
|
General disorders
Drowsiness
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/22
|
52.4%
11/21
|
|
General disorders
Allergies
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/22
|
23.8%
5/21
|
|
General disorders
Feeling Cold
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/22
|
14.3%
3/21
|
|
Infections and infestations
Ear infection
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/22
|
4.8%
1/21
|
|
Renal and urinary disorders
Enuresis
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/22
|
4.8%
1/21
|
|
General disorders
Nose bleed
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/22
|
9.5%
2/21
|
|
Cardiac disorders
Increased heart rate
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/22
|
4.8%
1/21
|
|
General disorders
Decreased appetite
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/22
|
4.8%
1/21
|
|
General disorders
Restlessness
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/22
|
4.8%
1/21
|
|
General disorders
Influenza
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/22
|
4.8%
1/21
|
|
General disorders
Other
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/22
|
4.8%
1/21
|
Additional Information
Robert Findling, MD, MBA, Director, Child and Adolescent Psychiatry
Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place