Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression
Information source: Stanford University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder, Major
Intervention: Ropinirole CR (Drug)
Phase: N/A
Status: Completed
Sponsored by: Stanford University Official(s) and/or principal investigator(s):
Charles Debattista, Principal Investigator, Affiliation: Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
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.
Clinical Details
Official title: Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: HamD
Secondary outcome: MADRS
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Depression Research Clinic, Psychiatry Department, Stanford School of Medicine, Stanford, California 9430, United States
Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information
Starting date: January 2006
Ending date: October 2007
Last updated: May 16, 2008
|
