Ropinirole in the Treatment of Bipolar Depression

NCT ID: NCT00314821

Last Updated: 2017-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-03-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is 8 weeks long, with an optional additional 8 weeks. The study is placebo-controlled and patients are randomized to receive either ropinerol or placebo. Changes in depression, anxiety and overall psychiatric symptoms will be monitored during participation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ropinirole

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Any serious acute medical illness
* Any clinically serious evidence of suicidality or score of 3 or greater on suicide item on MADRS scale
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Emory University

OTHER

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Cambridge Health Alliance

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert T Dunn, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Cambridge Health Alliance

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Emory University

Atlanta, Georgia, United States

Site Status

Cambridge Health Alliance

Cambridge, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHA-IRB-0116/05/05

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bipolar Disorder Study for Men and Women
NCT00056277 COMPLETED PHASE3
Depression And Bipolar Disorder
NCT00274677 COMPLETED PHASE3
Decision-Making in Bipolar Disorder
NCT01463111 COMPLETED NA
Acute Treatment of Bipolar II Depression
NCT00074776 COMPLETED PHASE3