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

Primary Purpose

Depressive Disorder, Major

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ropinirole CR

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford University School of Medicine
Depression Research Clinic, Psychiatry Department, Stanford School of Medicine

Outcomes

Primary Outcome Measures

HamD

Secondary Outcome Measures

MADRS

Full Information

NCT ID

NCT00285727

First Posted

January 31, 2006

Last Updated

May 16, 2008

Sponsor

Stanford University

Collaborators

Duke University, GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00285727

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Stanford University

Collaborators

Duke University, GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Major

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Ropinirole CR

Primary Outcome Measure Information:

Title

HamD

Secondary Outcome Measure Information:

Title

MADRS

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles Debattista

Organizational Affiliation

Depression Research Clinic, Psychiatry Department, Stanford School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Depression Research Clinic, Psychiatry Department, Stanford School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

9430

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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