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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00285727
First Posted: February 2, 2006
Last Update Posted: May 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Duke University
GlaxoSmithKline
Information provided by:
Stanford University
  Purpose
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.

Condition Intervention
Depressive Disorder, Major Drug: Ropinirole CR

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • HamD

Secondary Outcome Measures:
  • MADRS

Estimated Enrollment: 60
Study Start Date: January 2006
Estimated Study Completion Date: October 2007
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285727


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
Stanford, California, United States, 9430
Sponsors and Collaborators
Stanford University
Duke University
GlaxoSmithKline
Investigators
Principal Investigator: Charles Debattista Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
  More Information

ClinicalTrials.gov Identifier: NCT00285727     History of Changes
Other Study ID Numbers: 2969
First Submitted: January 31, 2006
First Posted: February 2, 2006
Last Update Posted: May 19, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs