Anxiety & Depression Association of America

Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Purpose

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

Conditions

Schizophrenia
Bipolar I Disorder

Eligibility

Eligible Ages: Between 12 Years and 17 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 4
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Iloperidone	Open-label iloperidone	Drug: Iloperidone oral tablet Other names: VYV-683 FANAPT

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Vanda Pharmaceuticals

Study Contact

Vanda Pharmaceuticals Inc.
202-734-3400
clinicaltrials@vandapharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.