First Episode Psychosis Clinical Trial
Official title:
Efficacy and Safety With Ziprasidone in the Treatment of First-episode Schizophrenia Spectrum Disorder: Multi-center Study
The aim of the study is to investigate the efficacy and safety of ziprasidone in patients with first episode psychosis.
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Chonbuk National University Hospital | Pfizer |
Korea, Republic of,
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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