Status:
TERMINATED
Use of Risperidone in ECT for Treatment Resistant Depression
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Janssen, LP
Conditions:
Major Depression
Eligibility:
All Genders
18-89 years
Phase:
PHASE4
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.
Detailed Description
Medication resistance to antidepressant therapy, or Treatment-Resistant Depression (TRD), is the main reason, if not main indication, for which patients are presently referred for electroconvulsive th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00203723
Start Date
March 1 2005
End Date
May 1 2006
Last Update
May 18 2006
Active Locations (1)
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1
UCLA Npi&H
Los Angeles, California, United States, 90024