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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01157559 |
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Date of registration:
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30/06/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety With Ziprasidone in First-episode Psychosis
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Scientific title:
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Efficacy and Safety With Ziprasidone in the Treatment of First-episode Schizophrenia Spectrum Disorder: Multi-center Study |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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27 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01157559 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Korea, Republic of
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Key inclusion & exclusion criteria
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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.
Age minimum:
14 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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First Episode Psychosis
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Intervention(s)
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Drug: Ziprasidone
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Primary Outcome(s)
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Symptoms assessment by objective rating scales
[Time Frame: week 8]
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Symptoms assessment by objective rating scales
[Time Frame: week 1]
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Symptoms assessment by objective rating scales
[Time Frame: week 4]
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Symptoms assessment by objective rating scales
[Time Frame: week 2]
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Symptoms assessment by objective rating scales
[Time Frame: week 6]
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Secondary Outcome(s)
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Assessment of adverse events by objective rating scales and self report scales
[Time Frame: two-month.]
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Assessment of adverse events by objective rating scales and self report scales
[Time Frame: one-month]
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Secondary ID(s)
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2006-Zeldox in FEP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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