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Aripiprazole in Children and Adolescents With Bipolar I Disorder

Primary Purpose

Bipolar Disorder

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Aripiprazole

placebo

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Aripiprazole, Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features Exclusion Criteria: Patients with certain other psychological disorders Patients with a co-morbid serious, uncontrolled systemic illness Patients with significant risk of committing suicide

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Aripiprazole 10 mg tablet

Aripiprazole 30 mg tablet

Placebo

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

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).

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).

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).

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.

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.

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).

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).

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).

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).

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).

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.

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).

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).

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).

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).

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).

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).

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).

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).

Full Information

NCT ID

NCT00110461

First Posted

May 9, 2005

Last Updated

April 19, 2012

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00110461

Brief Title

Aripiprazole in Children and Adolescents With Bipolar I Disorder

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

February 2007 (Actual)

Study Completion Date

February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder

Keywords

Aripiprazole, Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

296 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Aripiprazole 10 mg tablet

Arm Title

Arm Type

Active Comparator

Arm Description

Aripiprazole 30 mg tablet

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Aripiprazole

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Aripiprazole

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo tablet

Primary Outcome Measure Information:

Title

Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4

Description

Time Frame

Baseline and Week 4

Secondary Outcome Measure Information:

Title

Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30

Description

Time Frame

Baseline and Week 30

Title

Change in Children's Global Assessment Scale (CGAS) Total Score at Week 4

Description

Time Frame

Baseline and Week 4

Title

Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4

Description

Time Frame

Baseline and Week 4

Title

Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4

Description

Time Frame

Baseline and Week 4

Title

Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4

Description

Time Frame

Baseline and Week 4

Title

Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4

Description

Time Frame

Baseline and Week 4

Title

Change in Children's Global Assessment (CGAS) Total Score at Week 30

Description

Time Frame

Baseline and Week 30

Title

Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30

Description

Time Frame

Baseline and Week 30

Title

Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4

Description

Time Frame

Baseline and Week 4

Title

Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30

Description

Time Frame

Baseline and Week 30

Title

Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4

Description

Time Frame

Baseline and Week 4

Title

Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30

Description

Time Frame

Baseline and Week 30

Title

Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30

Description

Time Frame

Baseline and Week 30

Title

Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30

Description

Time Frame

Baseline and Week 30

Title

Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4

Description

Time Frame

Baseline and Week 4

Title

Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30

Description

Time Frame

Baseline and Week 30

Title

Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4

Description

Time Frame

Baseline and Week 4

Title

Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30

Description

Time Frame

Baseline and Week 30

Title

Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4

Description

Time Frame

Baseline and Week 4

Title

Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30

Description

Time Frame

Baseline and Week 30

Title

Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30

Description

Time Frame

Baseline and Week 30

Title

Subject Response to Treatment at Week 4

Description

Time Frame

Baseline and Week 4

Title

Subject Response to Treatment at Week 30

Description

Time Frame

Baseline and Week 30

Title

Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4

Description

Time Frame

Baseline and Week 4

Title

Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30

Description

Time Frame

Baseline and Week 30

Title

Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4

Description

Time Frame

Baseline and Week 4

Title

Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30

Description

Time Frame

Baseline and Week 30

Title

Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4

Description

Time Frame

Baseline and Week 4

Title

Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30

Description

Time Frame

Baseline and Week 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Margaretta Nyilas, MD

Organizational Affiliation

Otsuka Pharmaceutical Development & Commercialization, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution

City

Scottsdale

State/Province

Arizona

Country

United States

Facility Name

Local Institution

City

Little Rock

State/Province

Arkansas

Country

United States

Facility Name

Local Institution

City

National City

State/Province

California

Country

United States

Facility Name

Local Institution

City

Orange

State/Province

California

Country

United States

Facility Name

Local Institution

City

Pasadena

State/Province

California

Country

United States

Facility Name

Local Institution

City

Sacramento

State/Province

California

Country

United States

Facility Name

Local Institution

City

San Diego

State/Province

California

Country

United States

Facility Name

Local Institution

City

Stanford

State/Province

California

Country

United States

Facility Name

Local Institution

City

Washington

State/Province

District of Columbia

Country

United States

Facility Name

Local Institution

City

Altamonte Springs

State/Province

Florida

Country

United States

Facility Name

Local Institution

City

Hialeah

State/Province

Florida

Country

United States

Facility Name

Local Institution

City

Jacksonville

State/Province

Florida

Country

United States

Facility Name

Local Institution

City

Miami

State/Province

Florida

Country

United States

Facility Name

Local Institution

City

North Miami

State/Province

Florida

Country

United States

Facility Name

Local Institution

City

Tampa

State/Province

Florida

Country

United States

Facility Name

Local Institution

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

Local Institution

City

Smyrna

State/Province

Georgia

Country

United States

Facility Name

Local Institution

City

Boise

State/Province

Idaho

Country

United States

Facility Name

Local Institution

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

Local Institution

City

Libertyville

State/Province

Illinois

Country

United States

Facility Name

Local Institution

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

Local Institution

City

Kansas City

State/Province

Kansas

Country

United States

Facility Name

Local Institution

City

Newton

State/Province

Kansas

Country

United States

Facility Name

Local Institution

City

Lexington

State/Province

Kentucky

Country

United States

Facility Name

Local Institution

City

Baton Rouge

State/Province

Louisiana

Country

United States

Facility Name

Local Institution

City

Lake Charles

State/Province

Louisiana

Country

United States

Facility Name

Local Institution

City

Shreveport

State/Province

Louisiana

Country

United States

Facility Name

Local Institution

City

Cambridge

State/Province

Massachusetts

Country

United States

Facility Name

Local Institution

City

Medford

State/Province

Massachusetts

Country

United States

Facility Name

Local Institution

City

Clinton Township

State/Province

Michigan

Country

United States

Facility Name

Local Institution

City

Rochester Hills

State/Province

Michigan

Country

United States

Facility Name

Local Institution

City

Kansas City

State/Province

Missouri

Country

United States

Facility Name

Local Institution

City

St. Louis

State/Province

Missouri

Country

United States

Facility Name

Local Institution

City

Las Vegas

State/Province

Nevada

Country

United States

Facility Name

Local Institution

City

Elmsford

State/Province

New York

Country

United States

Facility Name

Local Institution

City

New York City

State/Province

New York

Country

United States

Facility Name

Local Institution

City

Rochester

State/Province

New York

Country

United States

Facility Name

Local Institution

City

Stony Brook

State/Province

New York

Country

United States

Facility Name

Local Institution

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

Local Institution

City

Cleveland

State/Province

Ohio

Country

United States

Facility Name

Local Institution

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Local Institution

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

Local Institution

City

Charleston

State/Province

South Carolina

Country

United States

Facility Name

Local Institution

City

Memphis

State/Province

Tennessee

Country

United States

Facility Name

Local Institution

City

Bellaire

State/Province

Texas

Country

United States

Facility Name

Local Institution

City

Fort Worth

State/Province

Texas

Country

United States

Facility Name

Local Institution

City

Houston

State/Province

Texas

Country

United States

Facility Name

Local Institution

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

Local Institution

City

Herndon

State/Province

Virginia

Country

United States

Facility Name

Local Institution

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

Local Institution

City

Kirkland

State/Province

Washington

Country

United States

Facility Name

Local Institution

City

Spokane

State/Province

Washington

Country

United States

Facility Name

Local Institution

City

Milwaukee

State/Province

Wisconsin

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23480324

Citation

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.

Results Reference

derived

PubMed Identifier

23437959

Citation

Findling 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.

Results Reference

derived

PubMed Identifier

21823911

Citation

Mankoski 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.

Results Reference

derived

PubMed Identifier

19906348

Citation

Findling 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.

Results Reference

derived

Learn more about this trial

Aripiprazole in Children and Adolescents With Bipolar I Disorder

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Aripiprazole in Children and Adolescents With Bipolar I Disorder

Bipolar Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial