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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

Eligibility

Eligible Ages
Between 12 Years and 17 Years
Eligible Sex
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

ArmDescriptionAssigned Intervention
Experimental
Iloperidone 		Open-label iloperidone
  • Drug: Iloperidone
    oral tablet
    Other names:
    • VYV-683
    • FANAPT

Recruiting Locations

Vanda Investigational Site
Little Rock, Arkansas 72204
Contact:
202-734-3400

Vanda Investigational Site
Denver, Colorado 80202
Contact:
202-734-3400

Vanda Investigational Site
Atlanta, Georgia 30318
Contact:
202-734-3400

Vanda Investigational Site
Atlanta, Georgia 30331
Contact:
202-734-3400

Vanda Investigational Site
Decatur, Georgia 30030
Contact:
202-734-3400

Vanda Investigational Site
Cincinnati, Ohio 45221
Contact:
Vanda Pharmaceuticals
202-734-3400

Vanda Investigational Site
Garfield Heights, Ohio 44125
Contact:
202-734-3400

Vanda Investigational Site
Everett, Washington 98201
Contact:
202-734-3400

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.