A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar Depression.
Information source: Sheba Medical Center
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder; Major Depressive Disorder
Intervention: ropinirole (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Sheba Medical Center Official(s) and/or principal investigator(s):
Leon Grunhaus, MD, Principal Investigator, Affiliation: Jerusalem Mental Health Center
Overall contact:
Ari A Gershon, MD, Phone: +972-3-5349105, Email: agershon@sheba.health.gov.il
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Hamilton Depression Rating Scale Score
Secondary outcome: Montgomery Asberg Depression Rating Scale Score
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Ari A Gershon, MD, Phone: +972-3-5349105, Email: agershon@sheba.health.gov.il
Chaim Sheba Medical Center, Dept. of Psychiatry, Tel Hashomer 52621, Israel; Recruiting
Ari A Gershon, MD, Phone: +972-3-5349105, Email: agershon@sheba.health.gov.il
Jerusalem Mental Health Center, Jerusalem, Israel; Active, not recruiting
Additional Information
Starting date: April 2003
Last updated: June 8, 2006
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