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Completed

NCT Number: NCT00285727

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

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.

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropinirole CR

Drug

Primary outcomes

  1. HamD

Secondary outcomes

  1. MADRS

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Duke University
  • GlaxoSmithKline

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
Feb 2, 2006
Registry last updated
May 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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