NCT00314821

Brief Summary

To demonstrate efficacy and safety of Requip in in treating bipolar depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2005

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2008

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

1.7 years

First QC Date

April 13, 2006

Last Update Submit

April 17, 2017

Conditions

Bipolar Disorder

Keywords

bipolar disorder, ropinirole, depression

Outcome Measures

Primary Outcomes (1)

  • Primary outcome will be group differences between Requip and placebo in random effects linear regression analysis.

Secondary Outcomes (1)

  • The secondary outcomes will include predictors of response, such as insight into illness, comorbid anxiety symptoms, prior course of illness, previous treatment history with antidepressants, and other relevant clinical and demographic features.

Interventions

ropiniroleDRUG

Eligibility Criteria

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

You may qualify if:

  • Meet DSM-IV criteria for bipolar disorder
  • Current MADRS score \> 16
  • Current MRS-SADS score \< 10
  • Prior to participation in this study, each subject must sign an informed consent.

You may not qualify if:

  • Any serious acute medical illness
  • Any clinically serious evidence of suicidality or score of 3 or greater on suicide item on MADRS scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

Location

MeSH Terms

Conditions

Bipolar DisorderDepression

Interventions

ropinirole

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Robert T Dunn, MD,PhD

    Cambridge Health Alliance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2006

First Posted

April 17, 2006

Study Start

September 1, 2005

Primary Completion

June 1, 2007

Study Completion

March 17, 2008

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations

US(2)