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

Sponsor

Sheba Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00335205

Collaborator

Jerusalem Mental Health Center (Other)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Apr 1, 2003

Outcome Measures

Primary Outcome Measures

Hamilton Depression Rating Scale Score []

Secondary Outcome Measures

Montgomery Asberg Depression Rating Scale Score []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Jerusalem Mental Health Center	Jerusalem		Israel
2	Chaim Sheba Medical Center, Dept. of Psychiatry	Tel Hashomer		Israel	52621

Sponsors and Collaborators

Sheba Medical Center
Jerusalem Mental Health Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00335205

Other Study ID Numbers:

SHEBA-02-2690-LG-CTIL

First Posted:

Jun 9, 2006

Last Update Posted:

Jun 9, 2006

Last Verified:

Jun 1, 2006

Keywords provided by , ,

Additional relevant MeSH terms:

Disease

Depression

Depressive Disorder

Depressive Disorder, Major

Bipolar Disorder

Ropinirole

Study Results

No Results Posted as of Jun 9, 2006