Ropinirole in the Treatment of Bipolar Depression

Phase 4

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00314821
• Lead Sponsor: Cambridge Health Alliance

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-04-13
• Study First Submitted QC: 2006-04-13
• Study First Posted: 2006-04-17
• Primary Completion: 2007-06-01
• Study Completion: 2008-03-17
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Emory University; 🇺🇸 Atlanta, Georgia, United States

Cambridge Health Alliance; 🇺🇸 Cambridge, Massachusetts, United States