Ropinirole in the Treatment of Bipolar Depression

Cambridge Health Alliance

Status and phase

Completed

Phase 4

Conditions

Bipolar Disorder

Treatments

Drug: ropinirole

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00314821

CHA-IRB-0116/05/05

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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