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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00335205
Recruitment Status : Unknown
Verified June 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : June 9, 2006
Last Update Posted : June 9, 2006
Jerusalem Mental Health Center
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Major Depressive Disorder Drug: ropinirole Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar I and II Depression.
Study Start Date : April 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Hamilton Depression Rating Scale Score

Secondary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale Score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00335205

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Contact: Ari A Gershon, MD +972-3-5349105

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Jerusalem Mental Health Center Active, not recruiting
Jerusalem, Israel
Chaim Sheba Medical Center, Dept. of Psychiatry Recruiting
Tel Hashomer, Israel, 52621
Contact: Ari A Gershon, MD    +972-3-5349105   
Sponsors and Collaborators
Sheba Medical Center
Jerusalem Mental Health Center
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Principal Investigator: Leon Grunhaus, MD Jerusalem Mental Health Center
Layout table for additonal information Identifier: NCT00335205    
Other Study ID Numbers: SHEBA-02-2690-LG-CTIL
First Posted: June 9, 2006    Key Record Dates
Last Update Posted: June 9, 2006
Last Verified: June 2006
Keywords provided by Sheba Medical Center:
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs