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Efficacy and Safety With Ziprasidone in First-episode Psychosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01157559
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : July 7, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The aim of the study is to investigate the efficacy and safety of ziprasidone in patients with first episode psychosis.

Condition or disease Intervention/treatment Phase
First Episode Psychosis Drug: Ziprasidone Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety With Ziprasidone in the Treatment of First-episode Schizophrenia Spectrum Disorder: Multi-center Study
Primary Completion Date : June 2008
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Ziprasidone
    8 week prospective study

Outcome Measures

Primary Outcome Measures :
  1. Symptoms assessment by objective rating scales [ Time Frame: week 1 ]
    PANSS total score, SANS, clinical global impression scale, GAF

  2. Symptoms assessment by objective rating scales [ Time Frame: week 2 ]
    PANSS total score, SANS, clinical global impression scale, GAF

  3. Symptoms assessment by objective rating scales [ Time Frame: week 4 ]
    PANSS total score, SANS, clinical global impression scale, GAF

  4. Symptoms assessment by objective rating scales [ Time Frame: week 6 ]
    PANSS total score, SANS, clinical global impression scale, GAF

  5. Symptoms assessment by objective rating scales [ Time Frame: week 8 ]
    PANSS total score, SANS, clinical global impression scale, GAF, DAS-S


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria

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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157559


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

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
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: January 2007

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents