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

Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depressive Disorder, Major

Intervention: Ropinirole CR (Drug)

Phase: N/A

Status: Completed

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Charles Debattista, Principal Investigator, Affiliation: Depression Research Clinic, Psychiatry Department, Stanford School of Medicine

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.

Clinical Details

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

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

Primary outcome: HamD

Secondary outcome: MADRS

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

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

Stanford University School of Medicine, Stanford, California 94305, United States

Additional Information

Starting date: January 2006
Last updated: May 16, 2008

Page last updated: August 23, 2015

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