Use of Risperidone in ECT for Treatment Resistant Depression

• Status: Terminated
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: Janssen, LP
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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