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| Sponsor: | Sheba Medical Center |
|---|---|
| Collaborator: |
Jerusalem Mental Health Center |
| Information provided by: | Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT00335205 |
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 IV |
| 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. |
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2003 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ari A Gershon, MD | +972-3-5349105 | agershon@sheba.health.gov.il |
| 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 | |
| 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 |
| Study First Received: | June 8, 2006 |
| Last Updated: | June 8, 2006 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
|
ropinirole dopamine D2 depression bipolar |
|
Bipolar Disorder Depression Depressive Disorder Depressive Disorder, Major Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms Dopamine Dopamine Agents Ropinirole Cardiotonic Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions 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 Central Nervous System Agents Dopamine Agonists |