NCT00226317

Brief Summary

A systematic open-label prospective pilot study to assess aripirazole for acute bipolar depression, with a secondary assessment of longer-term mood stabilization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

3.7 years

First QC Date

September 12, 2005

Last Update Submit

April 17, 2017

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Depression state

    6 week study

Study Arms (1)

Aripiprazole in depression treatment

EXPERIMENTAL
Drug: Aripiprazole

Interventions

AripiprazoleDRUG
Aripiprazole in depression treatment

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV diagnosis of bipolar disorder, any subtype; MADRS \>16; MRS \< 10; not currently taking other mood stabilizers; women of reproductive potential must use an acceptable method of birth control

You may not qualify if:

  • Current substance abuse within past month; serious unstable medical condition; active suicidal ideation; pregnant, trying to become pregnant, or nursing; intent to continue or initiate herbal preparations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

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

Study Officials

  • Robert T Dunn, MD, PhD

    Cambridge Health Alliance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 27, 2005

Study Start

April 1, 2004

Primary Completion

December 1, 2007

Study Completion

February 1, 2008

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations

US(1)