A Study to Assess Change in Disease Activity and Adverse... | NCT04777357

ID	Type	Description	Link
2020-004758-32	EudraCT Number

Status Module

Description Module

Label	Type	Description	Intervention Names
Cariprazine	Experimental	Participants will receive flexible dose Cariprazine over a 6 week treatment period.	Drug: Cariprazine
Placebo	Placebo Comparator	Participants will receive Placebo over a 6 week treatment period.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Cariprazine	Drug	Oral Capsule	Cariprazine	Vraylar

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.	Baseline (Week 0) to Week 10
Abnormal Change from Baseline in Vital Signs	Change in vital signs like systolic and diastolic blood pressure will be assessed.	Baseline (Week 0) to Week 10
Number of Participants with Incidence of Abnormal Clinical Laboratory Test Results	Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed.	Baseline (Week 0) to Week 6
Change in Electrocardiogram (ECG)	12 -lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.	Baseline (Week 0) to Week 6
Change From Baseline in Simpson-Angus Scale (SAS)	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) primary diagnosis of bipolar I disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
Current depressive episode is more than 2 weeks and less than 12 months in duration.
Participant has a lifetime history of at least one manic episode.
Children's Depression Rating Scale - Revised (CDRS-R) score > = 45 at Visit 1 and Visit 2.
Young-Mania Rating Scale (YMRS) score < = 12 with YMRS Item 1 (elevated mood) score < = 2 at Visit 1 and Visit 2.
Clinical Global Impression-Severity (CGI-S) scale score of > = 4 (moderately ill) at Visit 1 and Visit 2.

Exclusion Criteria:

Participants with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder.
Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Screening Visit 1.
History of serotonin syndrome or neuroleptic malignant syndrome.
Four or more episodes of a mood disturbance within the 12 months before Visit 1.
DSM-5 diagnosis of intellectual disability (IQ < 70), autism spectrum disorders, or documented history of chromosomal disorder with developmental impairment.
History of seizures, with the exception of febrile seizures.
Significant head trauma, history of tumor of the CNS, or any other condition that predisposes to seizures.
Participant requires concomitant treatment with moderate or strong CYP3A4 inhibitors or with any CYP3A4 inducers.
Participant requires concomitant treatment with any prohibited medication, supplement, or herbal product, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component.
Use of a depot antipsychotic within 2 cycles of their respective dosing interval prior to Screening Visit 1.
Treatment with clozapine in a dose of >= 50 mg/d in the past 2 years.
History of or any current ocular disease including, but not limited to, retinal detachment, intraocular surgery, laser treatment, glaucoma, cataracts, or clinically significant ocular trauma (with the exception of refractive errors).

Name	Role	Phone	Extension	Email
ABBVIE CALL CENTER	Contact	844-663-3742		abbvieclinicaltrials@abbvie.com

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pillar Clinical Research /ID# 226504	Completed	Bentonville	Arkansas	72712	United States

IPD Sharing Statement Module

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior