Efficacy and Safety With Ziprasidone in the Treatment of First-episode Schizophrenia Spectrum Disorder: Multi-center Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 27
- Locations
- 3
- Primary Endpoint
- Symptoms assessment by objective rating scales
Study Overview
Brief Summary
The aim of the study is to investigate the efficacy and safety of ziprasidone in patients with first episode psychosis.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 45 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Symptoms assessment by objective rating scales
Time Frame: week 8
PANSS total score, SANS, clinical global impression scale, GAF, DAS-S
Symptoms assessment by objective rating scales
Time Frame: week 1
PANSS total score, SANS, clinical global impression scale, GAF
Symptoms assessment by objective rating scales
Time Frame: week 2
PANSS total score, SANS, clinical global impression scale, GAF
Symptoms assessment by objective rating scales
Time Frame: week 4
PANSS total score, SANS, clinical global impression scale, GAF
Symptoms assessment by objective rating scales
Time Frame: week 6
PANSS total score, SANS, clinical global impression scale, GAF
Secondary Outcomes
- Assessment of adverse events by objective rating scales and self report scales(two-month.)
- Assessment of adverse events by objective rating scales and self report scales(one-month)