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

NCT ID: NCT00335205

Last Updated: 2006-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Brief Summary

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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

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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.

Conditions

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Bipolar Disorder Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ropinirole

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jerusalem Mental Health Center

OTHER_GOV

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Leon Grunhaus, MD

Role: PRINCIPAL_INVESTIGATOR

Jerusalem Mental Health Center

Locations

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Jerusalem Mental Health Center

Jerusalem, , Israel

Site Status ACTIVE_NOT_RECRUITING

Chaim Sheba Medical Center, Dept. of Psychiatry

Tel Litwinsky, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ari A Gershon, MD

Role: CONTACT

[email protected]
+972-3-5349105

Facility Contacts

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Ari A Gershon, MD

Role: primary

[email protected]
+972-3-5349105

Other Identifiers

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SHEBA-02-2690-LG-CTIL

Identifier Type: -

Identifier Source: org_study_id