Efficacy and Safety With Ziprasidone in First-episode Psychosis

First Episode Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157559
• Other study ID #: 2006-Zeldox in FEP
• 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

Related Conditions & MeSH terms

• First Episode Psychosis
• Mental Disorders
• Psychotic Disorders

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