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

This study has been completed.

First Received on January 31, 2006. Last Updated on May 16, 2008 History of Changes

Sponsor:	Stanford University
Collaborators:	Duke University GlaxoSmithKline
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00285727

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:

MedlinePlus related topics: Depression

Drug Information available for: Ropinirole hydrochloride Ropinirole

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285727

Locations

United States, California
Depression Research Clinic, Psychiatry Department, Stanford School of Medicine
Stanford, California, United States, 9430
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Duke University

GlaxoSmithKline

Investigators

Principal Investigator:

Charles Debattista

Depression Research Clinic, Psychiatry Department, Stanford School of Medicine

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00285727 History of Changes
Other Study ID Numbers:	2969
Study First Received:	January 31, 2006
Last Updated:	May 16, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012