Efficacy and Safety With Ziprasidone in First-episode Psychosis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01157559

Enrollment

Registered

2010-07-07

Start date

Unknown

Completion date

2010-05-31

Last updated

2010-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First Episode Psychosis

Brief summary

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

Interventions

DRUGZiprasidone

8 week prospective study

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Symptoms assessment by objective rating scales	week 1	PANSS total score, SANS, clinical global impression scale, GAF

Secondary

Measure	Time frame	Description
Assessment of adverse events by objective rating scales and self report scales	one-month	Simpson and Angus rating scale, Barnes Akathisia rating scale and Abnormal Involuntary Movement Scale

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026