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

Phase 4

• Conditions: Bipolar Disorder; Major Depressive Disorder

• Registration Number: NCT00335205
• Lead Sponsor: Sheba Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-04
• Status Verified: 2006-06
• Study First Submitted: 2006-06-08
• Study First Submitted QC: 2006-06-08
• Last Update Submitted: 2006-06-08
• Study First Posted: 2006-06-09
• Last Update Posted: 2006-06-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale Score

Secondary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale Score

Trial Locations

Locations (2)

Chaim Sheba Medical Center, Dept. of Psychiatry; 🇮🇱 Tel Hashomer, Israel

Jerusalem Mental Health Center; 🇮🇱 Jerusalem, Israel