Ropinirole in the Treatment of Bipolar Depression

This study is currently recruiting participants.

Verified by Cambridge Health Alliance, October 2006

First Received: April 13, 2006 Last Updated: October 19, 2006 History of Changes

Sponsors and Collaborators:	Cambridge Health Alliance Emory University GlaxoSmithKline
Information provided by:	Cambridge Health Alliance
ClinicalTrials.gov Identifier:	NCT00314821

Purpose

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

Condition	Intervention	Phase
Bipolar Disorder	Drug: ropinirole	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Ropinirole in the Treatment of Depression in Bipolar Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Ropinirole hydrochloride Ropinirole

U.S. FDA Resources

Further study details as provided by Cambridge Health Alliance:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	40
Study Start Date:	February 2006
Estimated Study Completion Date:	April 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314821

Contacts

Contact: Vanessa A Stan, AB

617-591-6116

vstan@challiance.org

Locations

United States, Massachusetts
Cambridge Health Alliance	Recruiting
Cambridge, Massachusetts, United States, 02139
Contact: Vanessa A Stan, AB 617-591-6116 vstan@challiance.org

Sponsors and Collaborators

Cambridge Health Alliance

Emory University

GlaxoSmithKline

Investigators

Principal Investigator:

Robert T Dunn, MD,PhD

Cambridge Health Alliance

More Information

No publications provided

Study ID Numbers:	CHA-IRB-0116/05/05
Study First Received:	April 13, 2006
Last Updated:	October 19, 2006
ClinicalTrials.gov Identifier:	NCT00314821 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cambridge Health Alliance:

bipolar disorder, ropinirole, depression

Study placed in the following topic categories:

Ropinirole
Neurotransmitter Agents
Depression
Bipolar Disorder
Depressive Disorder
Dopamine Agonists
Behavioral Symptoms

Affective Disorders, Psychotic
Dopamine
Mental Disorders
Mood Disorders
Psychotic Disorders
Dopamine Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Ropinirole
Depression
Disease
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Antiparkinson Agents
Dopamine Agonists

Depressive Disorder
Pharmacologic Actions
Behavioral Symptoms
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009