Bipolar DisorderPhase 3NCT00110461
Aripiprazole in Children and Adolescents With Bipolar I Disorder
A Phase 3 study testing Aripiprazole in people with Bipolar Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 53 sites in United States.
Trial summary
The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 53 sitesUnited States
- Study dates
- Mar 2005to Feb 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features
Who cannot join
- Patients with certain other psychological disorders
- Patients with a co-morbid serious, uncontrolled systemic illness
- Patients with significant risk of committing suicide
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Local Institution
Altamonte Springs, Florida
Local Institution
Atlanta, Georgia
Local Institution
Baton Rouge, Louisiana
Local Institution
Bellaire, Texas
Local Institution
Boise, Idaho
Local Institution
Cambridge, Massachusetts
Local Institution
Charleston, South Carolina
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Chicago, Illinois
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Cincinnati, Ohio
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Cleveland, Ohio
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Clinton Township, Michigan
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Elmsford, New York
Local Institution
Fort Worth, Texas
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Herndon, Virginia
Local Institution
Hialeah, Florida
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Houston, Texas
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Indianapolis, Indiana
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Jacksonville, Florida
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Kansas City, Kansas
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Kansas City, Missouri
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Kirkland, Washington
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Lake Charles, Louisiana
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Las Vegas, Nevada
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Lexington, Kentucky
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Libertyville, Illinois
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Little Rock, Arkansas
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Medford, Massachusetts
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Memphis, Tennessee
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Miami, Florida
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Milwaukee, Wisconsin
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National City, California
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New York, New York
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Newton, Kansas
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North Miami, Florida
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Oklahoma City, Oklahoma
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Orange, California
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Pasadena, California
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Philadelphia, Pennsylvania
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Richmond, Virginia
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Rochester, New York
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Rochester Hills, Michigan
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Sacramento, California
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San Antonio, Texas
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San Diego, California
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Scottsdale, Arizona
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Shreveport, Louisiana
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Smyrna, Georgia
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Spokane, Washington
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St Louis, Missouri
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Stanford, California
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Stony Brook, New York
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Tampa, Florida
Local Institution
Washington D.C., District of Columbia
About this study
Official title: A Phase III Trial to Test the Safety and Efficacy of Two Doses of Aripiprazole in Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.
- Conditions
- Bipolar Disorder
- Being tested
- Aripiprazole, placebo
- Keywords
- Aripiprazole, Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features
- Medical subject headings
- Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Treatment Arm 1 (10 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, and aripiprazole 10 mg QD as the target dose starting on Day 5. Subjects remained on the 10 mg dose for the remainder of the treatment period Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase.
AripiprazoleDrug
Treatment Arm 2 (30 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, aripiprazole 10 mg QD for 2 days, aripiprazole 15 mg QD for 2 days, aripiprazole 20 mg QD for 2 days, aripiprazole 25 mg QD for 2 days, and aripiprazole 30 mg QD as the target dose starting on Day 13. Subjects remained on the 30 mg dose for the remainder of the treatment period. Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase.
placeboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Aripiprazole 10 mg tablet Receives: Drug: Aripiprazole |
| 2 | Active comparator | Aripiprazole 30 mg tablet Receives: Drug: Aripiprazole |
| 3 | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4
Change from Baseline to Week 4 in Y-MRS total score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through the continuation phase.)
The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).
Measured: Baseline and Week 4
Secondary outcomes (29)
Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30
Change from baseline to Week 30 in Y-MRS total score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).
Measured: Baseline and Week 30
Change in Children's Global Assessment Scale (CGAS) Total Score at Week 4
Change from baseline to Week 4 in CGAS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome).
Measured: Baseline and Week 4
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4
Change from baseline to Week 4 in CGI-BP mania score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).
Measured: Baseline and Week 4
Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4
Change from baseline to Week 4 in CDRS-R score, using last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).
Measured: Baseline and Week 4
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4
Change from baseline to Week 4 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed baseline and weekly through acute phase (Week 4). (Also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Measured: Baseline and Week 4
Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4
Change from baseline to Week 4 in ADHD-RS-IV Total score, using last observation carried forward. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) ADHD-RS-IV is an instrument for diagnosing ADHD in children/adolescents and for assessing treatment response. The scale contains 18 items linked directly to DSM-IV diagnostic criteria for ADHD. Parent questionnaire on home behaviors (Eng.) used in this study. Minimum score of 0 is a better outcome, maximum score of 54 is a worse outcome.
Measured: Baseline and Week 4
Change in Children's Global Assessment (CGAS) Total Score at Week 30
Change from baseline to Week 30 in CGAS total score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome).
Measured: Baseline and Week 30
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30
Change from baseline to Week 30 in CGI-BP mania score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).
Measured: Baseline and Week 30
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4
Change from baseline to Week 4 in CGI-BP severity depression score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4. (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).
Measured: Baseline and Week 4
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30
Change from baseline to Week 30 in CGI-BP severity depression score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).
Measured: Baseline and Week 30
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4
Change from baseline to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).
Measured: Baseline and Week 4
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30
Change from baseline to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).
Measured: Baseline and Week 30
Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30
Change from baseline to Week 30 in CDRS-R score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).
Measured: Baseline and Week 30
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30
Change from baseline to Week 30 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase(Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Measured: Baseline and Week 30
Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4
Change from baseline to Week 4 in GBI Total Subject Version Mania score, using the LOCF. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Measured: Baseline and Week 4
Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30
Change from baseline to Week 30 in GBI Total Subject Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase (Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score of 0=better outcome, maximum score of 60=worse outcome.
Measured: Baseline and Week 30
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4
Change from baseline to Week 4 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Measured: Baseline and Week 4
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30
Change from Baseline to Week 30 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Measured: Baseline and Week 30
Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4
Change from Baseline to Week 4 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by subject. Symptoms wrated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Measured: Baseline and Week 4
Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30
Change from baseline to Week 30 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.
Measured: Baseline and Week 30
Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30
Change from baseline to Week 30 in ADHD-RS-IV Total score, using the LOCF.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The ADHD-RS-IV is an instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. The scale contains 18 items and is linked directly to DSM-IV diagnostic criteria for ADHD. The parent questionnaire on home behaviors (English) was used in this study. Minimum score of 0 = better outcome, maximum score of 54 = worse outcome.
Measured: Baseline and Week 30
Subject Response to Treatment at Week 4
Percentage of Subjects with a 50% or higher reduction from baseline in Young Mania Rating Scale (Y-MRS) total score at Week 4.
Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).
Measured: Baseline and Week 4
Subject Response to Treatment at Week 30
Percentage of Subjects with a 50% or higher reduction from baseline in Y-MRS total score at Week 30.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).
Measured: Baseline and Week 30
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4
Change from previous phase to Week 4 in CGI-BP mania score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).
Measured: Baseline and Week 4
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30
Change from previous phase to Week 30 in CGI-BP mania score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).
Measured: Baseline and Week 30
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4
Change from previous phase to Week 4 in CGI-BP severity depression score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).
Measured: Baseline and Week 4
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30
Change from previous phase to Week 30 in CGI-BP severity depression score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).
Measured: Baseline and Week 30
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4
Change from previous phase to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).
Measured: Baseline and Week 4
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30
Change from previous phase to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward.
Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.
The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).
Measured: Baseline and Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2005 (estimated)
- Study startMar 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Margaretta Nyilas, MD, Study director, Otsuka Pharmaceutical Development & Commercialization, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110461
- Sponsor's protocol ID
- 31-03-240
- Status last verified
- Apr 2012
- First submitted
- 9 May 2005
- Last updated
- 21 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Youngstrom E, Zhao J, Mankoski R, Forbes RA, Marcus RM, Carson W, McQuade R, Findling RL. Clinical significance of treatment effects with aripiprazole versus placebo in a study of manic or mixed episodes associated with pediatric bipolar I disorder. J Child Adolesc Psychopharmacol. 2013 Mar;23(2):72-9. doi: 10.1089/cap.2012.0024. Epub 2013 Mar 12.
PubMed 23480324Findling RL, Correll CU, Nyilas M, Forbes RA, McQuade RD, Jin N, Ivanova S, Mankoski R, Carson WH, Carlson GA. Aripiprazole for the treatment of pediatric bipolar I disorder: a 30-week, randomized, placebo-controlled study. Bipolar Disord. 2013 Mar;15(2):138-49. doi: 10.1111/bdi.12042.
PubMed 23437959Mankoski R, Zhao J, Carson WH, Mathew SJ, Forbes RA. Young mania rating scale line item analysis in pediatric subjects with bipolar I disorder treated with aripiprazole in a short-term, double-blind, randomized study. J Child Adolesc Psychopharmacol. 2011 Aug;21(4):359-64. doi: 10.1089/cap.2010.0100. Epub 2011 Aug 8.
PubMed 21823911Findling RL, Nyilas M, Forbes RA, McQuade RD, Jin N, Iwamoto T, Ivanova S, Carson WH, Chang K. Acute treatment of pediatric bipolar I disorder, manic or mixed episode, with aripiprazole: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2009 Oct;70(10):1441-51. doi: 10.4088/JCP.09m05164yel.
PubMed 19906348
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial to Test the Safety and Efficacy of Two Doses of Aripiprazole in Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
- ClinicalTrials.gov ID
- NCT00110461
- Acronym / sponsor ID
- 31-03-240
- Conditions
- Bipolar Disorder
- Keywords
- Aripiprazole, Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 10 May 2005 (estimated)
- Results
- Posted 21 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AripiprazoleAripiprazole 10 mg tablet |
| 2 | Active comparator | Drug: AripiprazoleAripiprazole 30 mg tablet |
| 3 | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features
Key exclusion criteria (3 listed)
- Patients with certain other psychological disorders
- Patients with a co-morbid serious, uncontrolled systemic illness
- Patients with significant risk of committing suicide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AripiprazoleTreatment Arm 1 (10 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, and aripiprazole 10 mg QD as the target dose starting on Day 5. Subjects remained on the 10 mg dose for the remainder of the treatment period Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase. | Drug | 1 |
| AripiprazoleTreatment Arm 2 (30 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, aripiprazole 10 mg QD for 2 days, aripiprazole 15 mg QD for 2 days, aripiprazole 20 mg QD for 2 days, aripiprazole 25 mg QD for 2 days, and aripiprazole 30 mg QD as the target dose starting on Day 13. Subjects remained on the 30 mg dose for the remainder of the treatment period. Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase. | Drug | 2 |
| placeboPlacebo tablet | Drug | 3 |
Primary outcome
Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4
Time frame: Baseline and Week 4
Change from Baseline to Week 4 in Y-MRS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through the continuation phase.) The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).
29 secondary outcomes
Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30
Time frame: Baseline and Week 30
Change in Children's Global Assessment Scale (CGAS) Total Score at Week 4
Time frame: Baseline and Week 4
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4
Time frame: Baseline and Week 4
Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4
Time frame: Baseline and Week 4
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4
Time frame: Baseline and Week 4
Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4
Time frame: Baseline and Week 4
Change in Children's Global Assessment (CGAS) Total Score at Week 30
Time frame: Baseline and Week 30
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30
Time frame: Baseline and Week 30
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4
Time frame: Baseline and Week 4
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30
Time frame: Baseline and Week 30
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4
Time frame: Baseline and Week 4
Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30
Time frame: Baseline and Week 30
Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30
Time frame: Baseline and Week 30
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30
Time frame: Baseline and Week 30
Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4
Time frame: Baseline and Week 4
Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30
Time frame: Baseline and Week 30
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4
Time frame: Baseline and Week 4
Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30
Time frame: Baseline and Week 30
Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4
Time frame: Baseline and Week 4
Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30
Time frame: Baseline and Week 30
Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30
Time frame: Baseline and Week 30
Subject Response to Treatment at Week 4
Time frame: Baseline and Week 4
Subject Response to Treatment at Week 30
Time frame: Baseline and Week 30
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4
Time frame: Baseline and Week 4
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30
Time frame: Baseline and Week 30
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4
Time frame: Baseline and Week 4
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30
Time frame: Baseline and Week 30
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4
Time frame: Baseline and Week 4
Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30
Time frame: Baseline and Week 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23480324Youngstrom E, Zhao J, Mankoski R, Forbes RA, Marcus RM, Carson W, McQuade R, Findling RL. Clinical significance of treatment effects with aripiprazole versus placebo in a study of manic or mixed episodes associated with pediatric bipolar I disorder. J Child Adolesc Psychopharmacol. 2013 Mar;23(2):72-9. doi: 10.1089/cap.2012.0024. Epub 2013 Mar 12.
- Derived from this study: PubMed 23437959Findling RL, Correll CU, Nyilas M, Forbes RA, McQuade RD, Jin N, Ivanova S, Mankoski R, Carson WH, Carlson GA. Aripiprazole for the treatment of pediatric bipolar I disorder: a 30-week, randomized, placebo-controlled study. Bipolar Disord. 2013 Mar;15(2):138-49. doi: 10.1111/bdi.12042.
- Derived from this study: PubMed 21823911Mankoski R, Zhao J, Carson WH, Mathew SJ, Forbes RA. Young mania rating scale line item analysis in pediatric subjects with bipolar I disorder treated with aripiprazole in a short-term, double-blind, randomized study. J Child Adolesc Psychopharmacol. 2011 Aug;21(4):359-64. doi: 10.1089/cap.2010.0100. Epub 2011 Aug 8.
- Derived from this study: PubMed 19906348Findling RL, Nyilas M, Forbes RA, McQuade RD, Jin N, Iwamoto T, Ivanova S, Carson WH, Chang K. Acute treatment of pediatric bipolar I disorder, manic or mixed episode, with aripiprazole: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2009 Oct;70(10):1441-51. doi: 10.4088/JCP.09m05164yel.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaretta Nyilas, MD study director
Otsuka Pharmaceutical Development & Commercialization, Inc.
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aripiprazole in people with Bipolar Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 53 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4 (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00110461, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2012.