Back to resultsRopinirole in the Treatment of Bipolar Depression
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ropinirole
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring bipolar disorder, ropinirole, depression
Eligibility Criteria
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
Sites / Locations
- Emory University
- Cambridge Health Alliance
Outcomes
Primary Outcome Measures
Primary outcome will be group differences between Requip and placebo in random effects linear regression analysis.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00314821
First Posted
April 13, 2006
Last Updated
April 17, 2017
Sponsor
Cambridge Health Alliance
Collaborators
Emory University, GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00314821
Brief Title
Ropinirole in the Treatment of Bipolar Depression
Official Title
A Randomized, Double-blind, Placebo-controlled Study of the Efficacy of Ropinirole in the Treatment of Depression in Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (Actual)
Primary Completion Date
June 1, 2007 (Actual)
Study Completion Date
March 17, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cambridge Health Alliance
Collaborators
Emory University, GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
bipolar disorder, ropinirole, depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ropinirole
Primary Outcome Measure Information:
Title
Primary outcome will be group differences between Requip and placebo in random effects linear regression analysis.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert T Dunn, MD,PhD
Organizational Affiliation
Cambridge Health Alliance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Cambridge Health Alliance
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ropinirole in the Treatment of Bipolar Depression
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