Efficacy and Safety With Ziprasidone in First-episode Psychosis

Overview

The aim of the study is to investigate the efficacy and safety of ziprasidone in patients with first episode psychosis.

Full Title of Study: “Efficacy and Safety With Ziprasidone in the Treatment of First-episode Schizophrenia Spectrum Disorder: Multi-center Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2008

Interventions

  • Drug: Ziprasidone
    • 8 week prospective study

Clinical Trial Outcome Measures

Primary Measures

  • Symptoms assessment by objective rating scales
    • Time Frame: week 1
    • PANSS total score, SANS, clinical global impression scale, GAF
  • Symptoms assessment by objective rating scales
    • Time Frame: week 2
    • PANSS total score, SANS, clinical global impression scale, GAF
  • Symptoms assessment by objective rating scales
    • Time Frame: week 4
    • PANSS total score, SANS, clinical global impression scale, GAF
  • Symptoms assessment by objective rating scales
    • Time Frame: week 6
    • PANSS total score, SANS, clinical global impression scale, GAF
  • Symptoms assessment by objective rating scales
    • Time Frame: week 8
    • PANSS total score, SANS, clinical global impression scale, GAF, DAS-S

Secondary Measures

  • Assessment of adverse events by objective rating scales and self report scales
    • Time Frame: one-month
    • Simpson and Angus rating scale, Barnes Akathisia rating scale and Abnormal Involuntary Movement Scale
  • Assessment of adverse events by objective rating scales and self report scales
    • Time Frame: two-month.
    • Simpson and Angus rating scale, Barnes Akathisia rating scale and Abnormal Involuntary Movement Scale

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who meet DSM-IV criteria for first episode schizophrenia, schizophreniform disorder and schizoaffective disorder Exclusion Criteria:

  • Patients with previously prescribed antipsychotic medication in 2 weeks or more – patients with substance-induced psychotic disorder, serious suicide attempt, neurological disorder, etc.

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chonbuk National University Hospital
  • Collaborator
    • Pfizer
  • Provider of Information About this Clinical Study
    • Young Chul Chung/Professor of Psychiatry, Chonbuk National University Hospital, Jeonju, Korea

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