Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression

Not Applicable

Completed

• Conditions: Depressive Disorder, Major

• Registration Number: NCT00285727
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-31
• Study First Submitted QC: 2006-02-01
• Study First Posted: 2006-02-02
• Study Completion: 2007-10
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-16
• Last Update Posted: 2008-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
HamD

Secondary Outcome Measures

Name	Time	Method
MADRS

Trial Locations

Locations (2)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Depression Research Clinic, Psychiatry Department, Stanford School of Medicine; 🇺🇸 Stanford, California, United States