A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.

AbbVie

Status and phase: Enrolling; Phase 3

Conditions: Bipolar I Disorder; Depression

Treatments: Drug: Placebo; Drug: Cariprazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04777357

2020-004758-32 (EudraCT Number)

3112-301-001

Details and patient eligibility

About

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population.

Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide.

Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Enrollment: 380 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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380 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive Placebo over a 6 week treatment period.

Treatment:

Drug: Placebo

Cariprazine

Experimental group

Description:

Participants will receive flexible dose Cariprazine over a 6 week treatment period.

Treatment:

Drug: Cariprazine