Open-label Ziprasidone Study for Psychosis Treatment in Adolescents

Completed · Phase 3

Conditions studied: Schizophreniform Disorder, Schizoaffective Disorder, Psychosis, Depressive Disorder, Major, Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT00421954

Run by

New York State Psychiatric Institute

People needed

8

Starts

2006-05-01

Expected to finish

2009-05-01

Last updated by the study team

2017-01-13

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• NYSPI — New York, New York, United States

Full record on ClinicalTrials.gov

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