Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ropinirole CR
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major
Eligibility Criteria
Inclusion Criteria: Age 18 to 65 years old Currently experiencing major depression On at least an adequate dose of fluoxetine, paroxetine, sertraline, citalopram, escitalopram, venlafaxine, bupropion, mirtazapine or duloxetine for at least 6 weeks (monotherapy). Exclusion Criteria:1. Pregnant females or females of child bearing years not using adequate birth control in the opinion of the investigators Known sensitivity to ropinirole Significant medical conditions that would preclude safe participation in the study in the opinion of the investigators. Significant abnormalities observed in screening laboratory evaluation
Sites / Locations
- Stanford University School of Medicine
- Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
Outcomes
Primary Outcome Measures
HamD
Secondary Outcome Measures
MADRS
Full Information
NCT ID
NCT00285727
First Posted
January 31, 2006
Last Updated
May 16, 2008
Sponsor
Stanford University
Collaborators
Duke University, GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00285727
Brief Title
Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression
Official Title
Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
Collaborators
Duke University, GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This is an 8 week study for patients who are currently taking antidepressant medication but not fully responding. Ropinirole CR would be taken in conjunction with current antidepressant medication. Patients come into the clinic once a week when starting on the medication and then once every other week for the remainder of the 8 weeks.
Detailed Description
We hope to learn whether ropinirole CR (controlled release formulation) is safe and effective when taken with an antidepressant to reduce the symptoms of depression. Adults who have a diagnosis of major depression and are currently taking an adequate dose of antidepressant medication will be sought for participation. They will continue to take the antidepressant medication and will receive ropinirole CR, an investigational medication, for eight weeks during which information will be collected about mood and cognitive functioning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ropinirole CR
Primary Outcome Measure Information:
Title
HamD
Secondary Outcome Measure Information:
Title
MADRS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 to 65 years old
Currently experiencing major depression
On at least an adequate dose of fluoxetine, paroxetine, sertraline, citalopram, escitalopram, venlafaxine, bupropion, mirtazapine or duloxetine for at least 6 weeks (monotherapy). Exclusion Criteria:1. Pregnant females or females of child bearing years not using adequate birth control in the opinion of the investigators
Known sensitivity to ropinirole
Significant medical conditions that would preclude safe participation in the study in the opinion of the investigators.
Significant abnormalities observed in screening laboratory evaluation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Debattista
Organizational Affiliation
Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
9430
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression
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