Efficacy and Safety With Ziprasidone in First-episode Psychosis
1 other identifier
interventional
27
1 country
3
Brief Summary
The aim of the study is to investigate the efficacy and safety of ziprasidone in patients with first episode psychosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 30, 2010
CompletedFirst Posted
Study publicly available on registry
July 7, 2010
CompletedJuly 7, 2010
January 1, 2007
June 30, 2010
July 6, 2010
Conditions
Outcome Measures
Primary Outcomes (5)
Symptoms assessment by objective rating scales
PANSS total score, SANS, clinical global impression scale, GAF
week 1
Symptoms assessment by objective rating scales
PANSS total score, SANS, clinical global impression scale, GAF
week 2
Symptoms assessment by objective rating scales
PANSS total score, SANS, clinical global impression scale, GAF
week 4
Symptoms assessment by objective rating scales
PANSS total score, SANS, clinical global impression scale, GAF
week 6
Symptoms assessment by objective rating scales
PANSS total score, SANS, clinical global impression scale, GAF, DAS-S
week 8
Secondary Outcomes (2)
Assessment of adverse events by objective rating scales and self report scales
one-month
Assessment of adverse events by objective rating scales and self report scales
two-month.
Interventions
8 week prospective study
Eligibility Criteria
You may qualify if:
- Patients who meet DSM-IV criteria for first episode schizophrenia, schizophreniform disorder and schizoaffective disorder
You may not qualify if:
- Patients with previously prescribed antipsychotic medication in 2 weeks or more
- patients with substance-induced psychotic disorder, serious suicide attempt, neurological disorder, etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chonbuk National University Hospitallead
- Pfizercollaborator
Study Sites (3)
Department of Psychiatry, Chonbuk national University Hospital
Jeonju, South Korea
Heo psychiatric Hospital
Jeonju, South Korea
Jeonju Jesus Hospital
Jeonju, South Korea
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 30, 2010
First Posted
July 7, 2010
Primary Completion
June 1, 2008
Study Completion
May 1, 2010
Last Updated
July 7, 2010
Record last verified: 2007-01