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.

Official title

A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in Pediatric Subjects (10 to 17 Years of Age) in the Treatment of Depressive Episodes Associated With Bipolar I Disorder

Overview

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.

Interventions

• Drug Cariprazine
  Oral Capsule
• Drug Placebo
  Oral Capsule

Primary outcome measures

• Number of Participants with Adverse Events [Time frame: Baseline (Week 0) to Week 10]
• Abnormal Change from Baseline in Vital Signs [Time frame: Baseline (Week 0) to Week 10]
• Number of Participants with Incidence of Abnormal Clinical Laboratory Test Results [Time frame: Baseline (Week 0) to Week 6]
• Change in Electrocardiogram (ECG) [Time frame: Baseline (Week 0) to Week 6]
• Change From Baseline in Simpson-Angus Scale (SAS) [Time frame: Baseline (Week 0) to Week 6]
• Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: Baseline (Week 0) to Week 10]
• Change From Baseline in Barnes Akathisia Rating Scale (BARS) [Time frame: Baseline (Week 0) to Week 6]
• Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) [Time frame: Baseline (Week 0) to Week 6]
• Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score [Time frame: Baseline (Week 0) to Week 6]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 69 centers

• Pillar Clinical Research /ID# 226504 — Bentonville
• Advanced Research Center /ID# 227073 — Anaheim
• Care Access Research /ID# 226316 — Beverly Hills
• Inland Pyschiatric Medical Group - Chino /ID# 278667 — Chino
• ProScience Research Group /ID# 226223 — Culver City
• National Institute of Clinical Research - Garden Grove /ID# 262835 — Garden Grove
• Accellacare - Long Beach /ID# 279482 — Long Beach
• Duplicate_Alliance for Research - Long Beach /ID# 226522 — Long Beach
• … and 61 more centers

Russia · 10 centers

• Clinica of Glazunova /ID# 229416 — Krasnodar
• Duplicate_Scientific Centre of Personalized Medicine /ID# 226380 — Moscow
• Duplicate_Central Clinical Psychiatric Hospital /ID# 226381 — Moscow
• Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462 — Orenburg
• Psychotherapeutics Center Podderzhka /ID# 226348 — Stavropol
• Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226 — Nizhny Novgorod
• Psychiatric hospital #1 /ID# 226516 — Saint Petersburg
• National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 2265 — Saint Petersburg
• … and 2 more centers

Puerto Rico · 2 centers

• Dr. Samuel Sanchez PSC /ID# 245952 — Caguas
• GCM Medical Group /ID# 245951 — San Juan

Identifiers

NCT: NCT04777357 · 3112-301-001 · 2020-004758-32

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗