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Completed

NCT Number: NCT00314821

Ropinirole in the Treatment of Bipolar Depression

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

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Key information

Conditions

Bipolar Disorder Behavior Behavioral Symptoms Bipolar and Related Disorders Depression Mental Disorders Mood Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropinirole

Drug

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cambridge Health Alliance

Other

Collaborators

  • Emory University
  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Apr 17, 2006
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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