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Ropinirole in the Treatment of Bipolar Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Cambridge Health Alliance.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Emory University
GlaxoSmithKline
Information provided by:
Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT00314821
First received: April 13, 2006
Last updated: October 19, 2006
Last verified: October 2006
History of Changes
  Purpose

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


Condition Intervention Phase
Bipolar Disorder
 Drug: ropinirole
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

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

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

Keywords provided by Cambridge Health Alliance:
bipolar disorder, ropinirole, depression

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ropinirole
Antiparkinson Agents
 Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 13, 2013