Ropinirole in the Treatment of Bipolar Depression

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314821
• Other study ID #: CHA-IRB-0116/05/05
• Status: Completed
• Phase: Phase 4
• First received: April 13, 2006
• Last updated: April 17, 2017
• Start date: September 2005
• Est. completion date: March 17, 2008

Study information

• Verified date: April 2017
• Source: Cambridge Health Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 17, 2008
• Est. primary completion date: June 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression

Intervention

Drug:
• ropinirole

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Cambridge Health Alliance	Cambridge	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Cambridge Health Alliance	Emory University, GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome will be group differences between Requip and placebo in random effects linear regression analysis.
Secondary	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.