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Completed

NCT Number: NCT01157559

Efficacy and Safety With Ziprasidone in First-episode Psychosis

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

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Key information

Conditions

First Episode Psychosis

Age range

14 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Psychiatry, Chonbuk national University Hospital, Jeonju, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ziprasidone

Drug

8 week prospective study

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Primary completion
2008
Study completion
2010
First posted
Jul 7, 2010
Registry last updated
Jul 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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