A Study of Aripiprazole in Patients With Bipolar I Disord... | NCT00338273

Studies
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

NCT00338273

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Status

Withdrawn

Last Update Posted

Nov 8, 2013Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Bipolar Disorder

Interventions

Aripiprazole
Placebo

Countries

United States
India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Nov 2007Actual

Completion Date

Nov 2007Actual

First Submitted Date

Jun 15, 2006

First Submission Date that Met QC Criteria

Jun 15, 2006

First Posted Date

Jun 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2013

Last Update Posted Date

Nov 8, 2013Estimated

Name	Class
Otsuka America Pharmaceutical	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to evaluate flexible doses (5-30 mg) of aripiprazole in patients with bipolar depression.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A1	Active Comparator		Drug: Aripiprazole
A2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aripiprazole	Drug	Tablets, Oral, 5 - 30 mg, Once daily, 8 weeks.	A1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change from baseline to endpoint (Week 8 last observation carried forward = LOCF) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score

Secondary Outcomes

Measure	Description	Time Frame
Mean change from baseline to endpoint on the Clinical Global Impression-Bipolar Version, severity of illness score (depression)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatients
Must sign informed consent prior to protocol-related procedures

Exclusion Criteria:

Women who are pregnant, trying to become pregnant, or nursing
Significant risk of committing suicide
Any serious unstable medical conditions

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Durham	North Carolina		United States
Local Institution

Condition Browse Module

MeSH Terms

ID	Term
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068180	Aripiprazole

Ancestor Terms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones

Browse Leaves

Not provided

Browse Branches

Not provided