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

Depressive Disorder, Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285727
• Other study ID #: 2969
• Status: Completed
• Phase: N/A
• First received: January 31, 2006
• Last updated: May 16, 2008
• Start date: January 2006
• Est. completion date: October 2007

Study information

• Verified date: May 2008
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Ropinirole CR

Locations

Country	Name	City	State
United States	Depression Research Clinic, Psychiatry Department, Stanford School of Medicine	Stanford	California
United States	Stanford University School of Medicine	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	Duke University, GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HamD
Secondary	MADRS