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

NCT ID: NCT00285727

Last Updated: 2008-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-10-31

Brief Summary

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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

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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.

Conditions

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Depressive Disorder, Major

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ropinirole CR

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 65 years old
* Currently experiencing major depression

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Principal Investigators

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Charles Debattista

Role: PRINCIPAL_INVESTIGATOR

Depression Research Clinic, Psychiatry Department, Stanford School of Medicine

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Depression Research Clinic, Psychiatry Department, Stanford School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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2969

Identifier Type: -

Identifier Source: org_study_id