Ropinirole in the Treatment of Bipolar Depression

Cambridge Health Alliance40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bipolar Disorder

Interventions

ropiniroleDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (2)

Emory University

Atlanta, Georgia, United States

Cambridge Health Alliance

Cambridge, Massachusetts, United States

Outcomes

Primary Outcomes

Primary outcome will be group differences between Requip and placebo in random effects linear regression analysis.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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