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
Sponsor:
Collaborator:
Jerusalem Mental Health Center
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00335205
First received: June 8, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted

June 8, 2006
June 8, 2006
April 2003
Not Provided
Hamilton Depression Rating Scale Score
Same as current
No Changes Posted
Montgomery Asberg Depression Rating Scale Score
Same as current
Not Provided
Not Provided
 
A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar Depression.
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Bipolar Disorder
  • Major Depressive Disorder
Drug: ropinirole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: Ari A Gershon, MD +972-3-5349105 agershon@sheba.health.gov.il
Israel
 
NCT00335205
SHEBA-02-2690-LG-CTIL
Not Provided
Not Provided
Sheba Medical Center
Jerusalem Mental Health Center
Principal Investigator: Leon Grunhaus, MD Jerusalem Mental Health Center
Sheba Medical Center
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP