Status:
COMPLETED
Ropinirole in the Treatment of Bipolar Depression
Lead Sponsor:
Cambridge Health Alliance
Collaborating Sponsors:
Emory University
GlaxoSmithKline
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- Any serious acute medical illness
- Any clinically serious evidence of suicidality or score of 3 or greater on suicide item on MADRS scale
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 17 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00314821
Start Date
September 1 2005
End Date
March 17 2008
Last Update
April 18 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Emory University
Atlanta, Georgia, United States, 30322
2
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139