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 because the information has not been verified recently.
Verified June 2006 by Sheba Medical Center.
Recruitment status was  Recruiting
Jerusalem Mental Health Center
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
First received: June 8, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00335205

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

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

No publications provided

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

Keywords provided by Sheba Medical Center:

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Depressive Disorder, Major
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Dopamine Agents
Anti-Dyskinesia Agents
Antiparkinson Agents
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Central Nervous System Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 11, 2016