Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features. (ATTAIN 267)
This is an open-label study consisting of a screening period, a conversion/titration phase (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period.
The study will enroll new subjects (hereafter referred as "de novo" subjects) with schizophrenia, or bipolar I disorder, manic or mixed episode with or without psychotic features, and rollover subjects with schizophrenia from 31-09-266 (hereafter referred to as "Study 266"). All de novo subjects must enter the screening period of the study. Subjects who are screened and are not required to go through Phase 1 will complete a Phase 2 baseline visit prior to their participation in Phase 2.
Study Design: Treatment, Single Group Assignment, Open Label, Active Control, Safety/Efficacy Study
Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Long-term, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Flexible-Dose Oral Aripiprazole (OPC-14597) as Maintenance Treatment in Adolescent Patients With Schizophrenia or Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features|
- Adverse events and severe adverse events [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]The frequency and severity of AEs, SAEs (clinical and laboratory), and discontinuation from study due to AEs
- Lab and Urinalysis [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
Mean change from baseline and incidence of clinically significant abnormalities in clinical laboratory tests and urinalysis results (including fasting blood lipids, glucose and insulin, serum prolactin, hemoglobin A1C [HbA1c] and creatinine phosphokinase [CPK]), vital signs (supine and standing positions) and ECG parameters.
Review of physical examination findings
- Mean change from baseline of z-scores for height and body weight, mean changes of BMI and waist circumference
- Mean change from baseline on the AIMS, SAS, and BARS
- The frequency of symptom items for the clinician-administered New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment: (NY-AACENT).
- Baseline and postbaseline Tanner Staging
- Analysis of potential suicide events recorded on the C-SSRS
- Time to discontinuation due to AE
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Phase 1 and Phase 2
Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg) pill taken orally once per day
Show 101 Study Locations
|Study Director:||Eva Kohegyi, MD||Otsuka Pharmaceutical Development and Commercialization, Inc.|