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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01157559
Other study ID # 2006-Zeldox in FEP
Secondary ID
Status Completed
Phase Phase 4
First received June 30, 2010
Last updated July 6, 2010
Est. completion date May 2010

Study information

Verified date January 2007
Source Chonbuk National University Hospital
Contact n/a
Is FDA regulated No
Health authority Republic of Korea: Chonbuk National University Hospital Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date May 2010
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 14 Years to 45 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Ziprasidone
8 week prospective study

Locations

Country Name City State
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

Sponsors (2)

Lead Sponsor Collaborator
Chonbuk National University Hospital Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Symptoms assessment by objective rating scales PANSS total score, SANS, clinical global impression scale, GAF week 1 No
Primary Symptoms assessment by objective rating scales PANSS total score, SANS, clinical global impression scale, GAF week 2 No
Primary Symptoms assessment by objective rating scales PANSS total score, SANS, clinical global impression scale, GAF week 4 No
Primary Symptoms assessment by objective rating scales PANSS total score, SANS, clinical global impression scale, GAF week 6 No
Primary Symptoms assessment by objective rating scales PANSS total score, SANS, clinical global impression scale, GAF, DAS-S week 8 No
Secondary 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 one-month No
Secondary 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 two-month. No
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