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 |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Vanda Pharmaceuticals
