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Efficacy and Safety With Ziprasidone in First-episode Psychosis

Primary Purpose

First Episode Psychosis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ziprasidone
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for First Episode Psychosis

Eligibility Criteria

14 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Psychiatry, Chonbuk national University Hospital
  • Heo psychiatric Hospital
  • Jeonju Jesus Hospital

Outcomes

Primary Outcome Measures

Symptoms assessment by objective rating scales
PANSS total score, SANS, clinical global impression scale, GAF
Symptoms assessment by objective rating scales
PANSS total score, SANS, clinical global impression scale, GAF
Symptoms assessment by objective rating scales
PANSS total score, SANS, clinical global impression scale, GAF
Symptoms assessment by objective rating scales
PANSS total score, SANS, clinical global impression scale, GAF
Symptoms assessment by objective rating scales
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
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
Simpson and Angus rating scale, Barnes Akathisia rating scale and Abnormal Involuntary Movement Scale

Full Information

First Posted
June 30, 2010
Last Updated
July 6, 2010
Sponsor
Chonbuk National University Hospital
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01157559
Brief Title
Efficacy and Safety With Ziprasidone in First-episode Psychosis
Official Title
Efficacy and Safety With Ziprasidone in the Treatment of First-episode Schizophrenia Spectrum Disorder: Multi-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chonbuk National University Hospital
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First Episode Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Intervention Description
8 week prospective study
Primary Outcome Measure Information:
Title
Symptoms assessment by objective rating scales
Description
PANSS total score, SANS, clinical global impression scale, GAF
Time Frame
week 1
Title
Symptoms assessment by objective rating scales
Description
PANSS total score, SANS, clinical global impression scale, GAF
Time Frame
week 2
Title
Symptoms assessment by objective rating scales
Description
PANSS total score, SANS, clinical global impression scale, GAF
Time Frame
week 4
Title
Symptoms assessment by objective rating scales
Description
PANSS total score, SANS, clinical global impression scale, GAF
Time Frame
week 6
Title
Symptoms assessment by objective rating scales
Description
PANSS total score, SANS, clinical global impression scale, GAF, DAS-S
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Assessment of adverse events by objective rating scales and self report scales
Description
Simpson and Angus rating scale, Barnes Akathisia rating scale and Abnormal Involuntary Movement Scale
Time Frame
one-month
Title
Assessment of adverse events by objective rating scales and self report scales
Description
Simpson and Angus rating scale, Barnes Akathisia rating scale and Abnormal Involuntary Movement Scale
Time Frame
two-month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Department of Psychiatry, Chonbuk national University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Heo psychiatric Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Jeonju Jesus Hospital
City
Jeonju
Country
Korea, Republic of

12. IPD Sharing Statement

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Efficacy and Safety With Ziprasidone in First-episode Psychosis

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