Open-Label, Flexible-dose Study to Evaluate the Long-Term... | NCT04578756

NCT04578756

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cariprazine Dose 1	Experimental	Participants with Schizophrenia (age 13 to 17 years and < 40 kg body weight) will receive cariprazine.	Drug: Cariprazine Flexible Dose
Cariprazine Dose 2	Experimental	Participants with Schizophrenia (age 13 to 17 years and >= 40 kg body weight) will receive cariprazine.	Drug: Cariprazine Flexible Dose
Cariprazine Dose 3	Experimental	Participants with Bipolar I Disorder (age 10 to 12 years and <40 kg body weight) will receive cariprazine.	Drug: Cariprazine Flexible Dose
Cariprazine Dose 4	Experimental	Participants with Bipolar I Disorder (age 10 to 12 years and >= 40 kg body weight) will receive cariprazine.	Drug: Cariprazine Flexible Dose
Cariprazine Dose 5	Experimental	Participants with Bipolar I Disorder (age 13 to 17 years and < 40 kg body weight) will receive cariprazine.	Drug: Cariprazine Flexible Dose
Cariprazine Dose 6

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cariprazine Flexible Dose	Drug	1 capsule to be taken orally at approximately the same time of day (morning or evening)	Cariprazine Dose 1 Cariprazine Dose 10

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period	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.	Baseline Day 1 to Week 59
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters	Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance.	Baseline Day 1 to Week 52
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters	Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance.	Baseline Day 1 to Week 59
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)	A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report.	Baseline Day 1 to Week 52
Number of Participants With Suicidal Ideation or Suicidal Behavior as Recorded on the Columbia-Suicide Severity Rating (C-SSRS) Scale	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".

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia or bipolar I disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL) at the Screening Visit 1 (for de novo subjects, or as previously confirmed in parent study for subjects who completed Study 3112-301-001 or M21-465).
De novo participants must have normal physical examination findings, clinical laboratory test results, and electrocardiogram (ECG) results at Screening Visit 1. Abnormal results must not be clinically significant as determined by the investigator. Participants enrolling after completion of Study M21-465 or 3112-301-001 have had monitoring of laboratory tests, physical examinations, and ECGs at the completion visit of the parent studies.
Participant must have a caregiver (parent or legally authorized representative) who is willing and able to be responsible for safety monitoring of the participant, provide information about the participant's condition, oversee administration of study intervention, and accompany the participant to all study visits.

Exclusion Criteria:

Participants with DSM-5-TR diagnosis of major depressive disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition. Participants with ASD that is associated with Rett disorder, fragile-X syndrome, or childhood disintegrative disorder.
Prior DSM-5-TR diagnosis of intellectual disability (IQ < 70) for schizophrenia and bipolar I disorder participants. Prior DSM-5-TR diagnosis of profound intellectual disability (IQ < 25) for ASD participants.
Participant has a condition or is in a situation, which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Harmonex Neuroscience Research /ID# 234938		Dothan	Alabama	36303	United States
Pillar Clinical Research /ID# 236434

IPD Sharing Statement Module

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders