NCT00203723

Brief Summary

The purpose of this study is to determine if the combination of risperidone and ECT improves a patient's response in depression compared to ECT alone.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

May 18, 2006

Status Verified

May 1, 2006

First QC Date

September 13, 2005

Last Update Submit

May 17, 2006

Conditions

Major Depression

Keywords

mood disorderaffective disorderdepressiontreatment-resistant

Outcome Measures

Primary Outcomes (1)

  • Scores on depression scales after 6 ECT treatments

Secondary Outcomes (1)

  • Scores on Clinical Global Impression Scales and Symptom Checklist

Interventions

RisperidoneDRUG

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 to 89 years, inclusive
  • Male or female
  • Inpatient or outpatient ECT with a current diagnosis of unipolar or bipolar depression, with or without psychosis, according to DSM-IV criteria. HAM-D (17-item) score \> 17 and MADRS score \> 18 at screening and at first treatment session.

You may not qualify if:

  • MMSE \< 23
  • Inability to consent to ECT
  • Current diagnosis of schizophrenia or schizoaffective disorder
  • Current diagnosis of Parkinson's Disease or any Dementia, including Lewy Body Disease
  • History of allergic reaction to risperidone
  • History of Neuroleptic Malignant Syndrome
  • Current pregnancy or positive urine pregnancy test
  • Women who are breast-feeding
  • Active alcohol or illicit substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Npi&H

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorMood DisordersDepression

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Depressive DisorderMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Randall Espinoza, MD, MPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

March 1, 2005

Study Completion

May 1, 2006

Last Updated

May 18, 2006

Record last verified: 2006-05

Locations

US(1)