A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders

Viatris

Status and phase: Completed; Phase 2

Conditions: Schizophrenia; Bipolar Disorder; Schizoaffective Disorder

Treatments: Drug: Ziprasidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00650611

A1281123

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders

Enrollment: 63 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children and teens with Bipolar I Disorder (manic or mixed), schizophrenia or schizoaffective disorder
• Willingness to discontinue all antipsychotic medications during the study period

Exclusion criteria

• Patients who are clinically stable on treatments that are well tolerated
• Substance-induced psychotic disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Low-Dose Ziprasidone

Active Comparator group

Treatment:

Drug: Ziprasidone

Drug: Ziprasidone

High-Dose Ziprasidone

Active Comparator group

Treatment:

Drug: Ziprasidone

Drug: Ziprasidone