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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 recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00335205
First Posted: June 9, 2006
Last Update Posted: June 9, 2006
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.
Collaborator:
Jerusalem Mental Health Center
Information provided by:
Sheba Medical Center
  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 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00335205


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

Locations
Israel
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    agershon@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Jerusalem Mental Health Center
Investigators
Principal Investigator: Leon Grunhaus, MD Jerusalem Mental Health Center
  More Information

ClinicalTrials.gov Identifier: NCT00335205     History of Changes
Other Study ID Numbers: SHEBA-02-2690-LG-CTIL
First Submitted: June 8, 2006
First Posted: June 9, 2006
Last Update Posted: June 9, 2006
Last Verified: June 2006

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

Additional relevant MeSH terms:
Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Dopamine
Dopamine Agents
Ropinirole
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists