Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Vanda Pharmaceuticals

Status and phase: Enrolling; Phase 4

Conditions: Bipolar I Disorder; Schizophrenia

Treatments: Drug: Iloperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT05648591

VP-VYV-683-4101

Details and patient eligibility

About

To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.

Enrollment: 100 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is willing and able to provide assent and willing to complete all aspects of the study
• Patient's parent or legal guardian willing and able to provide consent
• Male or female patients 12 through 17 years of age (inclusive)
• Clinical diagnosis of either schizophrenia or bipolar I disorder

Exclusion criteria

• Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
• A positive test for drugs of abuse

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Iloperidone

Experimental group

Description:

Open-label iloperidone

Treatment:

Drug: Iloperidone