Status:
COMPLETED
Open-label Ziprasidone Study for Psychosis Treatment in Adolescents
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
Pfizer
Conditions:
Schizophreniform Disorder
Schizoaffective Disorder
Eligibility:
All Genders
13-17 years
Phase:
PHASE3
Brief Summary
This open-label study will assess the medication Geodon® (Ziprasidone) in pediatric patients, aged 13-17, diagnosed with psychotic disorder. Eligible adolescents will receive Geodon® for 7 weeks and s...
Detailed Description
This study is an open-label assessment of the feasibility of treating adolescents with psychotic disorders (schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified \[NOS...
Eligibility Criteria
Inclusion
- Children who meet DSM-IV criteria for the following psychotic disorders: schizophreniform disorder, schizoaffective disorder, psychosis NOS, major depressive disorder with psychotic features, and bipolar disorder with psychotic features.
- Children with an IQ of at least 70.
- Children who are in good physical health.
- The parent/guardian of the child must be willing to attend all study visits.
Exclusion
- Children who are currently receiving an effective treatment without detrimental side effects.
- Children who are allergic to Geodon®.
- Children who have previously failed to respond to an adequate trial of Geodon®.
- Females who are pregnant or breast-feeding.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00421954
Start Date
May 1 2006
End Date
May 1 2009
Last Update
January 13 2017
Active Locations (1)
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1
NYSPI
New York, New York, United States, 10032