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

Cambridge Health Alliance2 sites in 1 country40 target enrollmentSeptember 2005

ConditionsBipolar Disorder

Drugsropinirole

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Bipolar Disorder
Sponsor: Cambridge Health Alliance
Enrollment: 40
Locations: 2
Primary Endpoint: Primary outcome will be group differences between Requip and placebo in random effects linear regression analysis.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2005

End Date

March 17, 2008

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Cambridge Health Alliance

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.