Ropinirole in the Treatment of Bipolar Depression

• Status: Completed
• Trial end date: 2008-03-17
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge Health Alliance
• Collaborators: Emory University; GlaxoSmithKline
• Treatments: Ropinirole

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