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Ropinirole in the Treatment of Bipolar Depression

This study has been completed.
Sponsor:
Collaborators:
Emory University
GlaxoSmithKline
Information provided by (Responsible Party):
Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT00314821
First received: April 13, 2006
Last updated: April 17, 2017
Last verified: April 2017
  Purpose
To demonstrate efficacy and safety of Requip in in treating bipolar depression.

Condition Intervention Phase
Bipolar Disorder Drug: ropinirole Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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
Actual Study Start Date: September 2005
Study Completion Date: March 17, 2008
Primary Completion Date: June 1, 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

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

Locations
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
GlaxoSmithKline
Investigators
Principal Investigator: Robert T Dunn, MD,PhD Cambridge Health Alliance
  More Information

Responsible Party: Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT00314821     History of Changes
Other Study ID Numbers: CHA-IRB-0116/05/05
Study First Received: April 13, 2006
Last Updated: April 17, 2017

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

Additional relevant MeSH terms:
Depression
Bipolar Disorder
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017