Phase 3
Completed N=8
Open-label Ziprasidone Study for Psychosis Treatment in Adolescents
Schizophreniform Disorder · schizoaffective disorder · Psychosis · Depressive Disorder, Major
Source: ClinicalTrials.gov NCT00421954 ↗
Enrolled (actual)
8
Serious AEs
—
Results posted
Jan 2017
Primary outcomePrimary: Weight Gain and Other Side Effects
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Gain and Other Side Effects |
— | — |
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. Informational only — not medical advice.