NCT00338273

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_3

Geographic Reach
2 countries

8 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

November 8, 2013

Status Verified

February 1, 2012

Enrollment Period

11 months

First QC Date

June 15, 2006

Last Update Submit

November 7, 2013

Conditions

Bipolar Disorder

Keywords

Bipolar I disorder with major depressive episode

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

Study Arms (2)

A1

ACTIVE COMPARATOR
Drug: Aripiprazole

A2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AripiprazoleDRUG

Tablets, Oral, 5 - 30 mg, Once daily, 8 weeks.

Also known as: Abilify
A1
PlaceboDRUG

Tablets, Oral, 0 mg, Once daily, 8 weeks.

A2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients
  • Must sign informed consent prior to protocol-related procedures

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Local Institution

Durham, North Carolina, United States

Location

Local Institution

Ahmedabad, Gujarat, India

Location

Local Institution

Chennai, India

Location

Local Institution

Delhi, India

Location

Local Institution

Hyderabad, India

Location

Local Institution

Lucknow, India

Location

Local Institution

Mumbai, India

Location

Local Institution

Visakhapatnam, India

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 20, 2006

Study Start

December 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

November 8, 2013

Record last verified: 2012-02

Locations

IN(7)US(1)