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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.

This study is currently recruiting participants.
Verified by Sheba Medical Center, June 2006

Sponsors and Collaborators: Sheba Medical Center
Jerusalem Mental Health Center
Information provided by: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00335205
  Purpose

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 Intervention Phase
Bipolar Disorder
Major Depressive Disorder
Drug: ropinirole
Phase IV

MedlinePlus related topics:   Bipolar Disorder    Depression    Mental Health   

ChemIDplus related topics:   Ropinirole    Ropinirole hydrochloride    Dopamine    Dopamine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale Score

Secondary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale Score

Estimated Enrollment:   60
Study Start Date:   April 2003

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335205

Contacts
Contact: Ari A Gershon, MD     +972-3-5349105     agershon@sheba.health.gov.il    

Locations
Israel
Chaim Sheba Medical Center, Dept. of Psychiatry     Recruiting
      Tel Hashomer, Israel, 52621
      Contact: Ari A Gershon, MD     +972-3-5349105     agershon@sheba.health.gov.il    
Jerusalem Mental Health Center     Active, not recruiting
      Jerusalem, Israel

Sponsors and Collaborators
Sheba Medical Center
Jerusalem Mental Health Center

Investigators
Principal Investigator:     Leon Grunhaus, MD     Jerusalem Mental Health Center    
  More Information


Study ID Numbers:   SHEBA-02-2690-LG-CTIL
First Received:   June 8, 2006
Last Updated:   June 8, 2006
ClinicalTrials.gov Identifier:   NCT00335205
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
ropinirole  
dopamine  
D2  
depression  
bipolar  

Study placed in the following topic categories:
Ropinirole
Affective Disorders, Psychotic
Dopamine
Depression
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Cardiotonic Agents
Sympathomimetics
Physiological Effects of Drugs
Antiparkinson Agents
Cardiovascular Agents
Dopamine Agonists
Protective Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 14, 2008




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