NCT00335205

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2006

Completed
Last Updated

June 9, 2006

Status Verified

June 1, 2006

First QC Date

June 8, 2006

Last Update Submit

June 8, 2006

Conditions

Bipolar DisorderMajor Depressive Disorder

Keywords

ropiniroledopamineD2depressionbipolar

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale Score

Secondary Outcomes (1)

  • Montgomery Asberg Depression Rating Scale Score

Interventions

ropiniroleDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • CVA
  • Antipsychotic Medication
  • Drug or Alcohol Abuse
  • Active Suicidality
  • Rapid Cycling Bipolar Disorder
  • Neurologic or Dementing Illness
  • Psychosis
  • Parkinsonism
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jerusalem Mental Health Center

Jerusalem, Israel

ACTIVE NOT RECRUITING

Chaim Sheba Medical Center, Dept. of Psychiatry

Tel Litwinsky, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Bipolar DisorderDepressive Disorder, MajorDepression

Interventions

ropinirole

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersDepressive DisorderBehavioral SymptomsBehavior

Study Officials

  • Leon Grunhaus, MD

    Jerusalem Mental Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ari A Gershon, MD

CONTACT

+972-3-5349105agershon@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 8, 2006

First Posted

June 9, 2006

Study Start

April 1, 2003

Last Updated

June 9, 2006

Record last verified: 2006-06

Locations

IL(2)