Clinical trial NCT04777357: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Depression
Bipolar I Disorder
Keywords: Depression
RGH-188
Bipolar I Disorder
Vraylar
Cariprazine
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-03-02
Enrollment: 380
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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).

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Baseline (Week 0) to Week 10
measure: Change From Baseline in Simpson-Angus Scale (SAS)
timeFrame: Baseline (Week 0) to Week 6
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
timeFrame: Baseline (Week 0) to Week 6
measure: Change From Baseline in Barnes Akathisia Rating Scale (BARS)
timeFrame: Baseline (Week 0) to Week 6
measure: Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline (Week 0) to Week 10
measure: Abnormal Change from Baseline in Vital Signs
timeFrame: Baseline (Week 0) to Week 10
measure: Number of Participants with Incidence of Abnormal Clinical Laboratory Test Results
timeFrame: Baseline (Week 0) to Week 6
measure: Change in Electrocardiogram (ECG)
timeFrame: Baseline (Week 0) to Week 6
measure: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
timeFrame: Baseline (Week 0) to Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Pillar Clinical Research /ID# 226504
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center /ID# 227073
state: California
city: Beverly Hills
country: United States
facility: Care Access Research /ID# 226316
state: California
city: Culver City
country: United States
facility: ProScience Research Group /ID# 226223
state: California
city: Garden Grove
country: United States
facility: National Institute of Clinical Research - Garden Grove /ID# 262835
state: California
city: Long Beach
country: United States
facility: Duplicate_Alliance for Research - Long Beach /ID# 226522
state: California
city: Orange
country: United States
facility: CHOC Children's Hospital /ID# 260298
state: California
city: Orange
country: United States
facility: ATP Clinical Research- Orange /ID# 253719
state: California
city: Rancho Cucamonga
country: United States
facility: Prospective Research Innovations Inc /ID# 240774
state: California
city: San Diego
country: United States
facility: University of California, San Diego Department of Psychiatry /ID# 226463
state: California
city: San Jose
country: United States
facility: Lumos Clinical Research Center /ID# 262805
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group /ID# 227075
state: California
city: Doral
country: United States
facility: D&H Doral Research Center-Doral /ID# 255458
state: Florida
city: Homestead
country: United States
facility: Advanced Research Institute of Miami /ID# 228222
state: Florida
city: Miami Springs
country: United States
facility: South Florida Research Ph I-IV /ID# 240778
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services, Llc /Id# 229792
state: Florida
city: Miami
country: United States
facility: G+C Research Group, LLC /ID# 261399
state: Florida
city: Miami
country: United States
facility: Florida Research Center, Inc. /ID# 240775
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida /ID# 256757
state: Florida
city: Orlando
country: United States
facility: APG Research, LLC /ID# 226519
state: Florida
city: Orlando
country: United States
facility: Nova Psychiatry Inc. /ID# 270892
state: Florida
city: Pensacola
country: United States
facility: Panhandle Research and Medical Clinic, LLC /ID# 268522
state: Florida
city: Tamarac
country: United States
facility: D&H Tamarac Research Center /ID# 250434
state: Florida
city: Tampa
country: United States
facility: University of South Florida- Neuroscience Institute /ID# 246508
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research /ID# 226480
state: Georgia
city: Decatur
country: United States
facility: CenExcel iResearch LLC /ID# 228695
state: Georgia
city: Dunwoody
country: United States
facility: Atlanta Behavioral Research, LLC /ID# 226486
state: Georgia
city: Stockbridge
country: United States
facility: Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371
state: Georgia
city: Chicago
country: United States
facility: Ascension St. Elizabeth /ID# 240772
state: Illinois
city: Naperville
country: United States
facility: Baber Research Group /ID# 232279
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University /ID# 260705
state: Indiana
city: Shreveport
country: United States
facility: Benchmark Research /ID# 260714
state: Louisiana
city: Baltimore
country: United States
facility: The Kennedy Krieger Institute /ID# 226509
state: Maryland
city: Irvington
country: United States
facility: Med Clinical Research Partners LLC /ID# 240773
state: New Jersey
city: Mount Arlington
country: United States
facility: Duplicate_NeuroCognitive and Behavioral Institute, Inc /ID# 227077
state: New Jersey
city: Buffalo
country: United States
facility: UB Department of Psychiatry /ID# 226373
state: New York
city: Kinston
country: United States
facility: New Dawn Psychiatric Services PLLC /ID# 229782
state: North Carolina
city: Avon Lake
country: United States
facility: Quest Therapeutics of Avon Lake /ID# 226349
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 226465
state: Ohio
city: West Chester
country: United States
facility: CincyScience /ID# 226318
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company /ID# 227072
state: Oklahoma
city: Oklahoma City
country: United States
facility: SP Research, PLLC /ID# 259428
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group /ID# 240777
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals /ID# 260719
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research /ID# 226384
state: Oklahoma
city: Austin
country: United States
facility: BioBehavioral Research of Austin /ID# 227076
state: Texas
city: Beaumont
country: United States
facility: Beaumont Psychiatric Clinic /ID# 267484
state: Texas
city: Coppell
country: United States
facility: Texas Research Group /ID# 270050
state: Texas
city: Dallas
country: United States
facility: Relaro Medical Trials /ID# 227156
state: Texas
city: Friendswood
country: United States
facility: Earle Research /ID# 253782
state: Texas
city: Houston
country: United States
facility: McGovern Medical School /ID# 240779
state: Texas
city: Houston
country: United States
facility: Southwest Biomed Research Center LLC /ID# 226340
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates /ID# 240776
state: Texas
city: Mansfield
country: United States
facility: Livingspring Family Medical Center /ID# 262706
state: Texas
city: Plano
country: United States
facility: AIM Trials /ID# 226367
state: Texas
city: Richmond
country: United States
facility: Perceptive Pharma Research /ID# 262219
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of The Woodlands /ID# 226290
state: Texas
city: Bountiful
country: United States
facility: Pantheon Clinical Research /ID# 270879
state: Utah
city: Everett
country: United States
facility: Core Clinical Research /ID# 226374
state: Washington
city: Caguas
country: Puerto Rico
facility: Dr. Samuel Sanchez PSC /ID# 245952
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC /ID# 245951
city: Krasnodar
country: Russian Federation
facility: Clinica of Glazunova /ID# 229416
state: Krasnodarskiy Kray
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462
state: Orenburgskaya Oblast
city: Stavropol
country: Russian Federation
facility: Psychotherapeutics Center Podderzhka /ID# 226348
state: Stavropol Skiy Kray
city: Moscow
country: Russian Federation
facility: Scientific Centre of Personalized Medicine /ID# 226380
city: Moscow
country: Russian Federation
facility: Central Clinical Psychiatric Hospital /ID# 226381
city: Nizhny Novgorod
country: Russian Federation
facility: Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226
city: Saratov
country: Russian Federation
facility: Medgard Clinic /ID# 228598
city: Saratov
country: Russian Federation
facility: Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 226222
city: St. Petersburg
country: Russian Federation
facility: Psychiatric hospital #1 /ID# 226516
city: St. Petersburg
country: Russian Federation
facility: National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 226515
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: