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

Major Depressive Disorder Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00335205
• Other study ID #: SHEBA-02-2690-LG-CTIL
• Status: Recruiting
• Phase: Phase 4
• First received: June 8, 2006
• Last updated: June 8, 2006
• Start date: April 2003

Study information

• Verified date: June 2006
• Source: Sheba Medical Center
• Contact: Ari A Gershon, MD
• Phone: +972-3-5349105
• Email: agershon[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• ropinirole

Locations

Country	Name	City	State
Israel	Jerusalem Mental Health Center	Jerusalem
Israel	Chaim Sheba Medical Center, Dept. of Psychiatry	Tel Hashomer

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Jerusalem Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale Score
Secondary	Montgomery Asberg Depression Rating Scale Score