Ropinirole in the Treatment of Bipolar Depression

Completed · Phase 4

Conditions studied: Bipolar Disorder

In brief

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

Key facts

Study ID

NCT00314821

Run by

Cambridge Health Alliance

People needed

40

Starts

2005-09-01

Expected to finish

2008-03-17

Last updated by the study team

2017-04-18

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Any serious acute medical illness
• Any clinically serious evidence of suicidality or score of 3 or greater on suicide item on MADRS scale

Where it is running

• Emory University — Atlanta, Georgia, United States
• Cambridge Health Alliance — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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