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Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression

NCT00340379 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2014-08-19

Study results available
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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.

Conditions

  • Affective Disorders

Interventions

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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • National Institute of Mental Health and Neuro Sciences, India

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Frederick Cassidy, MD · Duke University

  • George Simpson, MD · University of Southern California

  • Ranga Krishnan, MD · Duke University

  • Sumant Khanna, MD · National Institute of Mental Health and Neuroscience

  • Adel Elsheshai, MD · Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2005-08-31
Completion
2005-08-31

Countries

  • United States
  • Egypt
  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00340379 on ClinicalTrials.gov