Efficacy and Safety With Ziprasidone in First-episode Psychosis

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01157559
First received: June 30, 2010
Last updated: July 6, 2010
Last verified: January 2007
  Purpose

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


Condition Intervention Phase
First Episode Psychosis
Drug: Ziprasidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety With Ziprasidone in the Treatment of First-episode Schizophrenia Spectrum Disorder: Multi-center Study

Resource links provided by NLM:


Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Symptoms assessment by objective rating scales [ Time Frame: week 1 ] [ Designated as safety issue: No ]
    PANSS total score, SANS, clinical global impression scale, GAF

  • Symptoms assessment by objective rating scales [ Time Frame: week 2 ] [ Designated as safety issue: No ]
    PANSS total score, SANS, clinical global impression scale, GAF

  • Symptoms assessment by objective rating scales [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    PANSS total score, SANS, clinical global impression scale, GAF

  • Symptoms assessment by objective rating scales [ Time Frame: week 6 ] [ Designated as safety issue: No ]
    PANSS total score, SANS, clinical global impression scale, GAF

  • Symptoms assessment by objective rating scales [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    PANSS total score, SANS, clinical global impression scale, GAF, DAS-S


Secondary Outcome Measures:
  • Assessment of adverse events by objective rating scales and self report scales [ Time Frame: one-month ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Simpson and Angus rating scale, Barnes Akathisia rating scale and Abnormal Involuntary Movement Scale


Enrollment: 27
Study Completion Date: May 2010
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ziprasidone
    8 week prospective study
  Eligibility

Ages Eligible for Study:   14 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157559

Locations
Korea, Republic of
Department of Psychiatry, Chonbuk national University Hospital
Jeonju, Korea, Republic of
Jeonju Jesus Hospital
Jeonju, Korea, Republic of
Heo psychiatric Hospital
Jeonju, Korea, Republic of
Sponsors and Collaborators
Chonbuk National University Hospital
Pfizer
  More Information

No publications provided

Responsible Party: Young Chul Chung/Professor of Psychiatry, Chonbuk National University Hospital, Jeonju, Korea
ClinicalTrials.gov Identifier: NCT01157559     History of Changes
Other Study ID Numbers: 2006-Zeldox in FEP
Study First Received: June 30, 2010
Last Updated: July 6, 2010
Health Authority: Republic of Korea: Chonbuk National University Hospital Institutional Review Board

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 22, 2014