A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar Depression.

Study Overview
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Brief Summary
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We hypothesize that depressed patients who have not responded to their current antidepressant medication will respond to the addition of ropinirole to their current regimen at a rate better than placebo.

Detailed Description
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Most pharmacologic treatments of depression rely on serotonergic and/or noradrenergic mechanisms. Yet, evidence both from animal studies and from human trials suggests a role for dopaminergic pathways and particularly for dopamine D2-like receptors in the treatment of depression. In recent years, two new selective agonists of dopamine D2-like receptors have come into clinical use for the treatment of parkinsonism. Preliminary evidence suggests that these drugs might be useful as antidepressants. We are testing whether one of these agonists, ropinirole, is an effective augmentation strategy in depressed patients in a double-blind, randomized, controlled trial. We are recruiting unipolar and bipolar patients who remained depressed (modified Hamilton Depression Rating Scale score greater than 16) despite at least 4 weeks of treatment with an adequate dose of antidepressant medication. Patients receive either 2mg of oral ropinirole or placebo twice daily added on to their current medication and are evaluated weekly over 7 weeks and are assessed weekly using two depression rating scales.

Official Title
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A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar I and II Depression.

Conditions
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Bipolar Disorder, Major Depressive Disorder

Intervention / Treatment
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* Drug: ropinirole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV Major Depression OR Bipolar I or II Disorder - Currently Depressed One month of a stable, adequate dose of antidepressant medication Bipolar patients must have a mood stabilizer At least 18 years old Modified HDRS-21 more than 16 (Scores reverse vegetative symptoms.) Informed Consent Exclusion Criteria: CVA Antipsychotic Medication Drug or Alcohol Abuse Active Suicidality Rapid Cycling Bipolar Disorder Neurologic or Dementing Illness Psychosis Parkinsonism Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ropinirole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale Score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale Score |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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D2, ropinirole, dopamine, depression, bipolar