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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.

S

Sheba Medical Center

Status and phase

Unknown
Phase 4

Conditions

Major Depressive Disorder
Bipolar Disorder

Treatments

Drug: ropinirole

Study type

Interventional

Funder types

Other

Identifiers

NCT00335205
SHEBA-02-2690-LG-CTIL

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

2

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Central trial contact

Ari A Gershon, MD

Data sourced from clinicaltrials.gov

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