Phase 3
N=8
Open-label Ziprasidone Study for Psychosis Treatment in Adolescents
Schizophreniform Disorder · Schizoaffective Disorder · Psychosis · Depressive Disorder, Major · Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00421954 ↗Enrolled (actual)
8
Serious AEs
—
Results posted
Jan 2017
Primary outcome: Primary: Weight Gain and Other Side Effects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ziprasidone (Drug)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Gain and Other Side Effects |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00421954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.