Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder

Primary outcomes

1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period

   Time frame: Baseline Day 1 to Week 59

   An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.

2. Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters

   Time frame: Baseline Day 1 to Week 52

   Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance.

3. Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters

   Time frame: Baseline Day 1 to Week 59

   Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance.

4. Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)

   Time frame: Baseline Day 1 to Week 52

   A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report.

5. Number of Participants With Suicidal Ideation or Suicidal Behavior as Recorded on the Columbia-Suicide Severity Rating (C-SSRS) Scale

   Time frame: Baseline Day 1 to Week 52

   C-SSRS is a clinician-rated scale that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 "wish to be dead," and 5 "active suicidal ideation with specific plan and intent". Suicidal behavior is classified on a 5-item scale: 0 "no suicidal behavior, and 4 "actual attempt".

6. Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)

   Time frame: Baseline Day 1 to Week 52

   AIMS assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. The first 10 items are rated on a none (0) to severe (4) scale. There are an additional 2 items on dental status that are answered yes or no.

7. Change From Baseline in Barnes Akathisia Rating Scale (BARS)

   Time frame: Baseline Day 1 to Week 52

   BARS is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia (each on a 4-point scale from normal [0] to severe [3]). In addition, there is a global severity for akathisia rated on a 6-point scale (absent [0] to severe akathisia [5]).

8. Change From Baseline in Simpson-Angus Scale (SAS)

   Time frame: Baseline Day 1 to Week 52

   SAS is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Each item ranges from 0 (normal) to 4 (extreme symptoms). The scale consists of 1 item measuring gait (hypokinesia), 6 items measuring rigidity, and 3 items measuring glabella tap, tremor, and salivation, respectively.

9. Number of Participants With Clinically Significant Changes From Baseline in Opthalmologic Parameters

   Time frame: Baseline Day 1 to Week 52

   Ocular examination parameters included Intraocular pressure (IOP) measurement, Best-corrected visual acuity (BCVA), color fundus photography, color vision testing using Hardy Rand and Rittler (HRR) plates, and assessment of Optical coherence tomography (OCT) and cataracts. The investigator assessed the results for clinical significance.