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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00635700 |
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Date of registration:
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06/03/2008 |
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Primary sponsor: |
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Public title:
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Ziprasidone in the Psychosis Prodrome
ZIP |
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Scientific title:
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Ziprasidone vs Placebo in the Prevention of Psychosis Among Symptomatic Adolescents and Young Adults at Prodromal Risk |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00635700 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Scott W Woods, MD |
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Address:
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Telephone:
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203 074 7038 |
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Email:
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scott.woods@yale.edu |
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Affiliation:
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Name:
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Scott W Woods, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Yale University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- SIPS criteria for psychosis prodrome
- clinically referred
Exclusion Criteria:
- prolonged QTc
- history of syncope
Age minimum:
16 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Psychosis Prodrome
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Intervention(s)
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Drug: placebo
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Drug: ziprasidone
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Primary Outcome(s)
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conversion to psychosis
[Time Frame: 6 months]
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Secondary Outcome(s)
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improvement SOPS total score
[Time Frame: 8 weeks]
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Secondary ID(s)
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0801003386
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IIR GA1281GE
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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