This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs
Timeframe: From Screening (up to 42 days prior to treatment start) through Week 52 (end of study) for SAEs; from Week 0 (Baseline) through Week 52 (End of Study) for AEs
Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52
Timeframe: Baseline, Week 8, Week 26, Week 52
Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52
Timeframe: Baseline, Week 8, Week 26, Week 52
Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint
Timeframe: Baseline, Week 8, Week 26, Week 52
Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities
Timeframe: At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52
Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities
Timeframe: At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52
Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities
Timeframe: At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52
Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities
Timeframe: At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52
Number of Potentially Clinically Relevant Vital Sign Abnormalities
Timeframe: At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)
Mean Change From Baseline in Patient Weight
Timeframe: At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)
Mean Change From Baseline by Time Period in Body Weight Z-Score
Timeframe: At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)
Mean Change From Baseline in Patient Body Mass Index (BMI)
Timeframe: At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)
Mean Change From Baseline By Time Period in BMI Z-Score
Timeframe: At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)