NCT00340379

Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression

A Comparison of Two Different Treatments for Major Depression With Psychotic Features: Ziprasidone vs. Combined Sertraline and Haloperidol

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Affective Disorders

Interventions

Type	Name	Description
DRUG	Ziprasidone	Target dosage 120-160mg/day based on tolerance
DRUG	Sertraline	Target dosage 150-200mg/day based on tolerance.
DRUG	Haloperidol	Target dosage 6-8mg/day based on tolerance.

Timeline

• Start date: 2003-04-01
• Primary completion: 2005-08-01
• Completion: 2005-08-01
• First posted: 2006-06-21
• Last updated: 2014-08-19
• Results posted: 2013-06-04

Locations

3 sites across 3 countries: United States, Egypt, India