Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression

Status Completed

Clinical Trial Summary

The purpose of this study is to compare ziprasidone (Geodon) monotherapy for the treatment of psychotic major depression (PMD)with an antidepressant/antipsychotic combined therapy.

Clinical Trial Description

Psychotic depression is a well-established DSM-IV diagnostic subtype indicating the presence of hallucinations and/or delusions as part of the clinical presentation. Currently the treatment of choice for psychotic depression is either electroconvulsive therapy or combination of antipsychotic and antidepressant medications. Ziprasidone will be compared to standard of care treatment comprising a combination of an antidepressant, sertraline and an antipsychotic, haloperidol, over a 12-week period. An additional 12-week extension phase is also included for responders to the initial study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00340379
Study type	Interventional
Source	Duke University
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	April 2003
Completion date	August 2005

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT03608449` - Doing More With Less": Optimizing Psychotherapeutic Services in the Mental Health System	N/A
Completed	`NCT02752295` - Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients	N/A
Completed	`NCT00163865` - A Pilot Study of Boredom in a Community Sample of Adolescents and a Clinical Sample of Adolescents	N/A
Completed	`NCT03033420` - Reducing the Rate and Duration of Re-ADMISsions Among Patients With Unipolar Disorder and Bipolar Disorder Using Smartphone-based Monitoring and Treatment - The RADMIS Trials	N/A
Completed	`NCT01125579` - Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness
Completed	`NCT03109028` - Mental Health in Refugees and Asylum Seekers	N/A
Completed	`NCT03667729` - The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia	N/A
Not yet recruiting	`NCT02095457` - Routine Outcome Monitoring in Mental Health Outpatient	N/A
Completed	`NCT01815398` - Cognitive Skills Training for Homeless Youth	N/A
Completed	`NCT02675257` - Depression and Diabetes Control Trial	N/A
Completed	`NCT05379244` - Better Sleep in Psychiatric Care - Depression, Anxiety and Trauma, Pilot Study	N/A
Completed	`NCT03335696` - Predicting MRI Abnormalities With Longitudinal Data of the Whitehall II Substudy
Completed	`NCT00288782` - PET Neuroimaging of [11C]Mirtazapine	Phase 4
Completed	`NCT00199940` - Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness	Phase 4
Recruiting	`NCT01182012` - Reduction of Cardiovascular Risk in Severe Mental Illness	Phase 4