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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.

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00335205
Enrollment
60
Registered
2006-06-09
Start date
2003-04-30
Completion date
Unknown
Last updated
2006-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Major Depressive Disorder

Keywords

ropinirole, dopamine, D2, depression, bipolar

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.

Interventions

DRUGropinirole

Sponsors

Jerusalem Mental Health Center
CollaboratorOTHER_GOV
Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Rating Scale Score

Secondary

MeasureTime frame
Montgomery Asberg Depression Rating Scale Score

Countries

Israel

Contacts

Primary ContactAri A Gershon, MD
agershon@sheba.health.gov.il+972-3-5349105

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026