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

June 8, 2006 updated by: Sheba Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel
        • Active, not recruiting
        • Jerusalem Mental Health Center
      • Tel Hashomer, Israel, 52621
        • Recruiting
        • Chaim Sheba Medical Center, Dept. of Psychiatry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Hamilton Depression Rating Scale Score

Secondary Outcome Measures

Outcome Measure
Montgomery Asberg Depression Rating Scale Score

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Jerusalem Mental Health Center

Investigators

  • Principal Investigator: Leon Grunhaus, MD, Jerusalem Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Registration Dates

First Submitted

June 8, 2006

First Submitted That Met QC Criteria

June 8, 2006

First Posted (Estimate)

June 9, 2006

Study Record Updates

Last Update Posted (Estimate)

June 9, 2006

Last Update Submitted That Met QC Criteria

June 8, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-02-2690-LG-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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