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Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00194012
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : May 5, 2014
Last Update Posted : June 26, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Robert L Findling, MD, University Hospitals Cleveland Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bipolar Disorder
Interventions Drug: Aripiprazole
Drug: Placebo
Enrollment 62
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Aripiprazole Placebo
Hide Arm/Group Description 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: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
Period Title: Randomized Phase
Started 31 31
Received More Than One Dose 30 29
Completed 15 6
Not Completed 16 25
Reason Not Completed
Lack of Efficacy             8             18
Study nonadherence             2             1
Withdrawal by Subject             3             3
Adverse Event             2             1
Participant reported having a rash             1             0
Emesis and enuresis             0             1
Oral/nasal twitching             0             1
Period Title: Open Label Extension (OLE)
Started 22 [1] 21 [2]
Completed 17 15
Not Completed 5 6
Reason Not Completed
Weight Gain             1             0
Drowsiness; Jittery             0             1
Lost to Follow-up             3             5
Lack of Efficacy             1             0
[1]
Participants from aripiprazole group started OLE (eligible even if randomized period not completed).
[2]
Participants from placebo group started OLE (eligible even if randomized period not completed).
Arm/Group Title Abilify Randomized Phase Placebo Randomized Phase Total
Hide Arm/Group Description 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: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole. Total of all reporting groups
Overall Number of Baseline Participants 30 29 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 59 participants
<=18 years
30
 100.0%
29
 100.0%
59
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 59 participants
Female
10
  33.3%
14
  48.3%
24
  40.7%
Male
20
  66.7%
15
  51.7%
35
  59.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 29 participants 59 participants
30 29 59
1.Primary Outcome
Title Young Mania Rating Scale (YMRS)
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Abilify Randomized Phase Placebo Randomized Phase
Hide Arm/Group Description:
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: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
24.8  (6.8) 21.6  (6.1)
2.Primary Outcome
Title Young Mania Rating Scale (YMRS)
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Abilify Randomized Phase Placebo Randomized Phase
Hide Arm/Group Description:
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: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
9.7  (9.2) 16.2  (8.5)
3.Primary Outcome
Title Young Mania Rating Scale (YMRS)
Hide Description 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.
Time Frame Open-Label Extension - 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Open-Label Extension (Abilify) Open-Label Extension (Placebo)
Hide Arm/Group Description:

Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.

All participants in the open-label extension were taking Abilify (aripiprazole).

Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.

All participants in the open-label extension were taking Abilify (aripiprazole).

Overall Number of Participants Analyzed 20 18
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
5.73  (5.98) 7.57  (5.12)
4.Secondary Outcome
Title Children's Depression Rating Scale-Revised (CDRS-R )
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aripiprazole Randomized Phase Placebo Randomized Phase
Hide Arm/Group Description:
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: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
33.7  (11.2) 30.3  (10.4)
5.Secondary Outcome
Title CDRS-R Children's Depression Rating Scale-Revised
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aripiprazole Randomized Phase Placebo Randomized Phase
Hide Arm/Group Description:
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: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
24.4  (7.5) 25.9  (8.5)
6.Secondary Outcome
Title CDRS-R Children's Depression Rating Scale-Revised
Hide Description 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.
Time Frame Open-Label Extension - 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Open-Label Extension (Abilify) Open-Label Extension (Placebo)
Hide Arm/Group Description:

Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.

All participants in the open-label extension were taking Abilify (aripiprazole).

Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.

All participants in the open-label extension were taking Abilify (aripiprazole).

Overall Number of Participants Analyzed 20 18
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
21.5  (5.48) 21.7  (5.54)
7.Secondary Outcome
Title Children's Global Assessment Scale (CGAS)
Hide Description

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.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aripiprazole Randomized Phase Placebo Randomized Phase
Hide Arm/Group Description:
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: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
56.1  (6.7) 57.5  (4.6)
8.Secondary Outcome
Title Children's Global Assessment Scale (CGAS)
Hide Description

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.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aripiprazole Randomized Phase Placebo Randomized Phase
Hide Arm/Group Description:
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: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
67.1  (11.2) 61.4  (8.7)
9.Secondary Outcome
Title Children's Global Assessment Scale (CGAS)
Hide Description

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.

Time Frame Open-Label Extension - 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Open-Label Extension (Abilify) Open-Label Extension (Placebo)
Hide Arm/Group Description:

Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.

All participants in the open-label extension were taking Abilify (aripiprazole).

Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.

All participants in the open-label extension were taking Abilify (aripiprazole).

Overall Number of Participants Analyzed 19 18
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
71.47  (8.49) 69.72  (6.47)
10.Secondary Outcome
Title Clinical Global Impressions Scale (CGI-Severity)
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aripiprazole Randomized Phase Placebo Randomized Phase
Hide Arm/Group Description:
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: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.2  (0.9) 3.8  (0.8)
11.Secondary Outcome
Title Clinical Global Impressions Scale (CGI-Severity)
Hide Description 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).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aripiprazole Randomized Phase Placebo Randomized Phase
Hide Arm/Group Description:
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: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.3  (1.4) 3.0  (1.1)
12.Secondary Outcome
Title Clinical Global Impressions Scale (CGI-Severity)
Hide Description 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).
Time Frame Open-Label Extension - 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Open-Label Extension (Abilify) Open-Label Extension (Placebo)
Hide Arm/Group Description:

Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.

All participants in the open-label extension were taking Abilify (aripiprazole).

Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.

All participants in the open-label extension were taking Abilify (aripiprazole).

Overall Number of Participants Analyzed 20 18
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1.85  (.875) 1.89  (.758)
13.Secondary Outcome
Title Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aripiprazole Randomized Phase Placebo Randomized Phase
Hide Arm/Group Description:
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: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
32.4  (12.4) 36.8  (12.5)
14.Secondary Outcome
Title Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aripiprazole Randomized Phase Placebo Randomized Phase
Hide Arm/Group Description:
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: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
21.0  (14.5) 32.1  (14.3)
15.Secondary Outcome
Title Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)
Hide Description 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.
Time Frame Open-Label Extension - 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Open-Label Extension (Abilify) Open-Label Extension (Placebo)
Hide Arm/Group Description:

Participants entered the open-label extension phase of the study. They were originally assigned to the Abilify (aripiprazole) group in the 12-week randomized phase of the study.

All participants in the open-label extension were taking Abilify (aripiprazole).

Participants entered the open-label extension phase of the study. They were originally assigned to the placebo group in the 12-week randomized phase of the study.

All participants in the open-label extension were taking Abilify (aripiprazole).

Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
18.1  (14.0) 28.1  (12.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abilify Randomized Phase Placebo Randomized Phase Open Label Extension (Abilify) Open Label Extension (Placebo)
Hide Arm/Group Description 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: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole. Previously randomized to Abilify group. Previously randomized to placebo group.
All-Cause Mortality
Abilify Randomized Phase Placebo Randomized Phase Open Label Extension (Abilify) Open Label Extension (Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/31 (0.00%)   0/22 (0.00%)   0/21 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Abilify Randomized Phase Placebo Randomized Phase Open Label Extension (Abilify) Open Label Extension (Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/31 (0.00%)   0/22 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abilify Randomized Phase Placebo Randomized Phase Open Label Extension (Abilify) Open Label Extension (Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/31 (77.42%)   13/31 (41.94%)   10/22 (45.45%)   13/21 (61.90%) 
Cardiac disorders         
Increased heart rate   0/31 (0.00%)  0/31 (0.00%)  0/22 (0.00%)  1/21 (4.76%) 
Gastrointestinal disorders         
Stomach ache  [1]  11/31 (35.48%)  7/31 (22.58%)  3/22 (13.64%)  6/21 (28.57%) 
Emesis   7/31 (22.58%)  0/31 (0.00%)  6/22 (27.27%)  1/21 (4.76%) 
Nausea   5/31 (16.13%)  2/31 (6.45%)  0/22 (0.00%)  2/21 (9.52%) 
Diarrhea   4/31 (12.90%)  2/31 (6.45%)  1/22 (4.55%)  0/21 (0.00%) 
General disorders         
Sedation  [2]  7/31 (22.58%)  2/31 (6.45%)  1/22 (4.55%)  4/21 (19.05%) 
Increased appetite  [3]  7/31 (22.58%)  1/31 (3.23%)  8/22 (36.36%)  1/21 (4.76%) 
Fever   4/31 (12.90%)  1/31 (3.23%)  0/22 (0.00%)  0/21 (0.00%) 
Dizziness   4/31 (12.90%)  2/31 (6.45%)  0/22 (0.00%)  1/21 (4.76%) 
Nasal Congestion   3/31 (9.68%)  1/31 (3.23%)  1/22 (4.55%)  0/21 (0.00%) 
Coughing   4/31 (12.90%)  0/31 (0.00%)  2/22 (9.09%)  0/21 (0.00%) 
Sore Throat   2/31 (6.45%)  1/31 (3.23%)  1/22 (4.55%)  0/21 (0.00%) 
Cold Symptoms  [4]  2/31 (6.45%)  1/31 (3.23%)  3/22 (13.64%)  0/21 (0.00%) 
Weight Gain   0/31 (0.00%)  0/31 (0.00%)  3/22 (13.64%)  2/21 (9.52%) 
Drowsiness  [5]  0/31 (0.00%)  0/31 (0.00%)  0/22 (0.00%)  11/21 (52.38%) 
Allergies  [6]  0/31 (0.00%)  0/31 (0.00%)  0/22 (0.00%)  5/21 (23.81%) 
Feeling Cold   0/31 (0.00%)  0/31 (0.00%)  0/22 (0.00%)  3/21 (14.29%) 
Nose bleed   0/31 (0.00%)  0/31 (0.00%)  0/22 (0.00%)  2/21 (9.52%) 
Decreased appetite   0/31 (0.00%)  0/31 (0.00%)  0/22 (0.00%)  1/21 (4.76%) 
Restlessness   0/31 (0.00%)  0/31 (0.00%)  0/22 (0.00%)  1/21 (4.76%) 
Influenza  [7]  0/31 (0.00%)  0/31 (0.00%)  0/22 (0.00%)  1/21 (4.76%) 
Other  [8]  0/31 (0.00%)  0/31 (0.00%)  0/22 (0.00%)  1/21 (4.76%) 
Infections and infestations         
Ear infection   0/31 (0.00%)  0/31 (0.00%)  0/22 (0.00%)  1/21 (4.76%) 
Musculoskeletal and connective tissue disorders         
Musculoskeletal Pain  [9]  5/31 (16.13%)  2/31 (6.45%)  4/22 (18.18%)  1/21 (4.76%) 
Injury  [10]  0/31 (0.00%)  0/31 (0.00%)  6/22 (27.27%)  2/21 (9.52%) 
Nervous system disorders         
Headache  [1]  15/31 (48.39%)  12/31 (38.71%)  8/22 (36.36%)  5/21 (23.81%) 
Renal and urinary disorders         
Enuresis   0/31 (0.00%)  0/31 (0.00%)  0/22 (0.00%)  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders         
Upper Respiratory Infection  [11]  0/31 (0.00%)  0/31 (0.00%)  1/22 (4.55%)  3/21 (14.29%) 
Skin and subcutaneous tissue disorders         
Rash   0/31 (0.00%)  0/31 (0.00%)  3/22 (13.64%)  0/21 (0.00%) 
Athletes Foot   0/31 (0.00%)  0/31 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Acne   0/31 (0.00%)  0/31 (0.00%)  0/22 (0.00%)  4/21 (19.05%) 
Indicates events were collected by systematic assessment
[1]
One case in the abilify group had a dosing reduction
[2]
One case in the placebo group had a dosing reduction
[3]
Per study protocol as previously outlined
[4]
Runny nose, Sneezing
[5]
Tired, Tiredness, Fatigue, Going to bed early
[6]
including nickel allergy
[7]
Flu
[8]
Can't remember music
[9]
Knee Pain, back ache
[10]
Broken leg, broken nose, heel injury
[11]
Sinus infection
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Findling, MD, MBA, Director, Child and Adolescent Psychiatry
Organization: Johns Hopkins University School of Medicine
Phone: 410-614-3225
EMail: rfindli1@jhmi.edu
Layout table for additonal information
Responsible Party: Robert L Findling, MD, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00194012     History of Changes
Other Study ID Numbers: At Risk
First Submitted: September 11, 2005
First Posted: September 19, 2005
Results First Submitted: June 26, 2013
Results First Posted: May 5, 2014
Last Update Posted: June 26, 2017