Ropinirole in the Treatment of Bipolar Depression - Tabular View

Tracking Information

First Received Date ^ICMJE

April 13, 2006

Last Updated Date

October 19, 2006

Start Date ^ICMJE

February 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00314821 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Ropinirole in the Treatment of Bipolar Depression

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Ropinirole in the Treatment of Depression in Bipolar Disorder

Brief Summary

To demonstrate efficacy and safety of Requip in bipolar disorder, depressive state.

Detailed Description

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

Drug: ropinirole

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

April 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Meet DSM-IV criteria for bipolar disorder, type II
Current MADRS score > 16
Current MRS-SADS score < 10
Prior to participation in this study, each subject must sign an informed consent.
All patients will be required to also take at least one other mood-stabilizing agent, defined as a standard agent (lithium, valproate, carbamazepine) or a novel anticonvulsant agent (oxcarbazepine, gabapentin, topiramate). If patients are not taking any of these agents on study initiation, they will be required to start one of these agents for at least two weeks before study initiation. Study inclusion criteria must be met after at least 2 weeks of treatment with one of these mood-stabilizing agents.

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

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Vanessa A Stan, AB

617-591-6116

vstan@challiance.org

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00314821

Responsible Party

Study ID Numbers ^ICMJE

CHA-IRB-0116/05/05

Study Sponsor ^ICMJE

Cambridge Health Alliance

Collaborators ^ICMJE

Emory University
GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Robert T Dunn, MD,PhD

Cambridge Health Alliance

Information Provided By

Cambridge Health Alliance

Verification Date

October 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP