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Ropinirole in the Treatment of Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00314821
Recruitment Status : Completed
First Posted : April 17, 2006
Last Update Posted : April 18, 2017
Emory University
Information provided by (Responsible Party):
Cambridge Health Alliance

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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: ropinirole Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Actual Study Start Date : September 2005
Actual Primary Completion Date : June 1, 2007
Actual Study Completion Date : March 17, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  • 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 at 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00314821

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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Cambridge Health Alliance
Emory University
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Principal Investigator: Robert T Dunn, MD,PhD Cambridge Health Alliance

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Responsible Party: Cambridge Health Alliance Identifier: NCT00314821    
Other Study ID Numbers: CHA-IRB-0116/05/05
First Posted: April 17, 2006    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Keywords provided by Cambridge Health Alliance:
bipolar disorder, ropinirole, depression
Additional relevant MeSH terms:
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Bipolar Disorder
Behavioral Symptoms
Mental Disorders
Bipolar and Related Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs