Back to resultsA Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar Depression.
Primary Purpose
Bipolar Disorder, Major Depressive Disorder
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
ropinirole
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring ropinirole, dopamine, D2, depression, bipolar
Eligibility 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
Sites / Locations
- Jerusalem Mental Health Center
- Chaim Sheba Medical Center, Dept. of PsychiatryRecruiting
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale Score
Secondary Outcome Measures
Montgomery Asberg Depression Rating Scale Score
Full Information
NCT ID
NCT00335205
First Posted
June 8, 2006
Last Updated
June 8, 2006
Sponsor
Sheba Medical Center
Collaborators
Jerusalem Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT00335205
Brief Title
A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar Depression.
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 Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
Collaborators
Jerusalem Mental Health Center
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Major Depressive Disorder
Keywords
ropinirole, dopamine, D2, depression, bipolar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ropinirole
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale Score
Secondary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale Score
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ari A Gershon, MD
Phone
+972-3-5349105
Email
agershon@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Grunhaus, MD
Organizational Affiliation
Jerusalem Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jerusalem Mental Health Center
City
Jerusalem
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Chaim Sheba Medical Center, Dept. of Psychiatry
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ari A Gershon, MD
Phone
+972-3-5349105
Email
agershon@sheba.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar Depression.
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