Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Depressive Disorder, Major |
Drug: Ropinirole CR |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression |
- HamD
- MADRS
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | October 2007 |
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| Depression Research Clinic, Psychiatry Department, Stanford School of Medicine | |
| Stanford, California, United States, 9430 | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Charles Debattista | Depression Research Clinic, Psychiatry Department, Stanford School of Medicine |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00285727 History of Changes |
| Other Study ID Numbers: | 2969 |
| Study First Received: | January 31, 2006 |
| Last Updated: | May 16, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Ropinirole Antiparkinson Agents Anti-Dyskinesia Agents |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013