Ropinirole in the Treatment of Bipolar Depression
Information source: Cambridge Health Alliance
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: ropinirole (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Cambridge Health Alliance Official(s) and/or principal investigator(s):
Robert T Dunn, MD,PhD, Principal Investigator, Affiliation: Cambridge Health Alliance
Overall contact:
Vanessa A Stan, AB, Phone: 617-591-6116, Email: vstan@challiance.org
Summary
To demonstrate efficacy and safety of Requip in bipolar disorder, depressive state.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Ropinirole in the Treatment of Depression in Bipolar Disorder
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Primary outcome will be group differences between Requip and placebo in random effects linear regression analysis.
Secondary outcome: 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.
Detailed description:
Primary outcome will be group differences between Requip and placebo in random effects linear
regression analysis. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Meet DSM-IV criteria for bipolar disorder, type II
- 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 for at least two weeks before 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 and Contacts
Vanessa A Stan, AB, Phone: 617-591-6116, Email: vstan@challiance.org
Cambridge Health Alliance, Cambridge, Massachusetts 02139, United States; Recruiting
Vanessa A Stan, AB, Phone: 617-591-6116, Email: vstan@challiance.org
Additional Information
Starting date: February 2006
Ending date: April 2006
Last updated: October 19, 2006
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