Ropinirole in the Treatment of Bipolar Depression

A Randomized, Double-blind, Placebo-controlled Study of the Efficacy of Ropinirole in the Treatment of Depression in Bipolar Disorder

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00314821

Enrollment

Registered

2006-04-17

Start date

2005-09-30

Completion date

2008-03-17

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

bipolar disorder, ropinirole, depression

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 overall psychiatric symptoms will be monitored during participation.

Interventions

DRUGropinirole

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026