Open-label Ziprasidone Study for Psychosis Treatment in Adolescents

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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 stay at the NYSPI Children's Day Unit (CDU) during the day. If clinically appropriate, they may also stay at the New York State Psychiatric Institute (NYSPI) Schizophrenia Research Unit (SRU) inpatient facility.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: Pfizer
• Treatments: Ziprasidone

Criteria

Inclusion Criteria:

1. 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.

2. Children with an IQ of at least 70.

3. Children who are in good physical health.

4. The parent/guardian of the child must be willing to attend all study visits.

Exclusion Criteria:

1. Children who are currently receiving an effective treatment without detrimental side effects.

2. Children who are allergic to Geodon®.

3. Children who have previously failed to respond to an adequate trial of Geodon®.

4. Females who are pregnant or breast-feeding.