NCT00174577

Brief Summary

The purpose of this study is to assess the safety and efficacy of risperidone augmentation in patients who have failed to respond or only partially responded to an adequate trial of an antidepressant.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2003

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

February 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

September 15, 2005

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

September 9, 2005

Conditions

Major Depression

Outcome Measures

Primary Outcomes (3)

  • Depression symptoms,change score on MADRS scale at 4 weeks

  • Group differences on HRS-D scores

  • Group differences on remission and improvement

Secondary Outcomes (2)

  • Between group differences on quality-of-life measures

  • Group differences of anxiety and psychosocial factors

Interventions

RisperidoneDRUG

Eligibility Criteria

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

You may qualify if:

  • patients with major depression or partially remitted depression
  • currently receiving an adequate trial of an antidepressant

You may not qualify if:

  • diagnosis of bipolar I or bipolar II disorder
  • psychotic features
  • substance dependence or abuse in the past three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University School of Medicine

Atlanta, Georgia, 30329, United States

Location

Mood Disorders Program - Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gabor I Keitner, M.D.

    Rhode Island Hospital/Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

February 1, 2003

Study Completion

February 1, 2005

Last Updated

September 15, 2005

Record last verified: 2005-09

Locations

US(2)