A Study of the Change in Disease State and Safety of Oral Cariprazine Capsules in the Treatment of Depression in Pediatric Participants (10 to 17 Years of Age) With Bipolar I Disorder

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04777357

Collaborator

(none)

380

Enrollment

Locations

Arms

45.1

Anticipated Duration (Months)

7.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Bipolar I Disorder	Drug: Cariprazine Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

380 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 28, 2021

Anticipated Primary Completion Date :

Jan 18, 2024

Anticipated Study Completion Date :

Jan 29, 2025

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants will receive Placebo over a 6 week treatment period.	Drug: Placebo Oral Capsule
Experimental: Cariprazine Participants will receive flexible dose Cariprazine over a 6 week treatment period.	Drug: Cariprazine Oral Capsule Other Names: Vraylar

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Participants will receive Placebo over a 6 week treatment period.

Drug: Placebo

Oral Capsule

Experimental: Cariprazine

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

Drug: Cariprazine

Oral Capsule

Other Names:

Vraylar

Outcome Measures

Primary Outcome Measures

Number of Participants with Adverse Events [Baseline (Week 0) to Week 10]
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.
Abnormal Change from Baseline in Vital Signs [Baseline (Week 0) to Week 10]
Change in vital signs like systolic and diastolic blood pressure will be assessed.
Number of Participants with Incidence of Abnormal Clinical Laboratory Test Results [Baseline (Week 0) to Week 6]
Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed.
Change in Electrocardiogram (ECG) [Baseline (Week 0) to Week 6]
12 -lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Change in Children's Depression Rating Scale - Revised (CDRS-S) Total Score [Baseline (Week 0) to Week 10]
The CDRS-R is a 17 item scale with items ranging from 1 to 5 or 1 to 7 used to assess depression and change in depression symptoms in children and adolescents. Scores greater than or equal to 40 are indicative of depression. Scores less than or equal to 28 are often used to define minimal or no symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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 4 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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pillar Clinical Research /ID# 226504	Bentonville	Arkansas	United States	72712
2	Advanced Research Center /ID# 227073	Anaheim	California	United States	92805
3	Care Access Research /ID# 226316	Beverly Hills	California	United States	90212
4	ProScience Research Group /ID# 226223	Culver City	California	United States	90230-6632
5	Alliance for Research - Long Beach /ID# 226522	Long Beach	California	United States	90807
6	Prospective Research Innovations Inc /ID# 240774	Rancho Cucamonga	California	United States	91730
7	University of California, San Diego Department of Psychiatry /ID# 226463	San Diego	California	United States	92103-8229
8	Pacific Clinical Research Management Group /ID# 227075	Upland	California	United States	91786-3676
9	Galiz Research - Palmetto Medical Plaza /ID# 226518	Hialeah	Florida	United States	33016
10	Advanced Research Institute of Miami /ID# 228222	Homestead	Florida	United States	33030-4613
11	South Florida Research Ph I-IV /ID# 240778	Miami Springs	Florida	United States	33166-7225
12	Columbus Clinical Services, Llc /Id# 229792	Miami	Florida	United States	33125-5114
13	Florida Research Center, Inc. /ID# 240775	Miami	Florida	United States	33174
14	Atlanta Center for Medical Research /ID# 226480	Atlanta	Georgia	United States	30331
15	iResearch Atlanta, LLC /ID# 228695	Decatur	Georgia	United States	30030
16	Atlanta Behavioral Research, LLC /ID# 226486	Dunwoody	Georgia	United States	30338
17	Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371	Stockbridge	Georgia	United States	30281
18	AMITA Health St. Mary and St. Elizabeth Medical Ctr /ID# 240772	Chicago	Illinois	United States	60622
19	Baber Research Group /ID# 232279	Naperville	Illinois	United States	60563-6502
20	The Kennedy Krieger Institute /ID# 226509	Baltimore	Maryland	United States	21205
21	Med Clinical Research Partners LLC /ID# 240773	Irvington	New Jersey	United States	07111
22	NeuroCognitive and Behavioral Institute, Inc /ID# 227077	Mount Arlington	New Jersey	United States	07856-1315
23	UB Department of Psychiatry /ID# 226373	Buffalo	New York	United States	14215
24	New Dawn Psychiatric Services PLLC /ID# 229782	Kinston	North Carolina	United States	28501-1603
25	Quest Therapeutics of Avon Lake /ID# 226349	Avon Lake	Ohio	United States	44012
26	University of Cincinnati /ID# 226465	Cincinnati	Ohio	United States	45219
27	CincyScience /ID# 226318	West Chester	Ohio	United States	45069
28	IPS Research Company /ID# 227072	Oklahoma City	Oklahoma	United States	73106
29	Sooner Clinical Research /ID# 226384	Oklahoma City	Oklahoma	United States	73112
30	Cutting Edge Research Group /ID# 240777	Oklahoma City	Oklahoma	United States	73116-1423
31	BioBehavioral Research of Austin /ID# 227076	Austin	Texas	United States	78759-5290
32	Relaro Medical Trials /ID# 227156	Dallas	Texas	United States	75243
33	McGovern Medical School /ID# 240779	Houston	Texas	United States	77054
34	Southwest Biomed Research Center LLC /ID# 226340	Houston	Texas	United States	77063
35	Red Oak Psychiatry Associates /ID# 240776	Houston	Texas	United States	77090-2641
36	AIM Trials /ID# 226367	Plano	Texas	United States	75093
37	Family Psychiatry of The Woodlands /ID# 226290	The Woodlands	Texas	United States	77381
38	Dr. Samuel Sanchez PSC /ID# 245952	Caguas		Puerto Rico	00727
39	GCM Medical Group PSC /ID# 245951	San Juan		Puerto Rico	00917-3104
40	Asociatia Comunitatea Oamenilor /ID# 226514	Craiova	Dolj	Romania	200157
41	Clinica de Neuropsihiatrie Infantila Timisoara /Id# 226347	Timisoara	Timis	Romania	300329
42	Psychotherapeutics Center Podderzhka /ID# 226348	Stavropol	Stavropol Skiy Kray	Russian Federation	355029
43	Clinica of Glazunova /ID# 229416	Krasnodar		Russian Federation	350051
44	Scientific Centre of Personalized Medicine /ID# 226380	Moscow		Russian Federation	105082
45	Central Clinical Psychiatric Hospital /ID# 226381	Moscow		Russian Federation	127083
46	Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226	Nizhny Novgorod		Russian Federation	603155
47	Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462	Orenburg		Russian Federation	460006
48	I. I. Skvortsov-Stepanov Psychiatric Hospital #3 /ID# 226346	Saint Petersburg		Russian Federation	197341
49	Medgard Clinic /ID# 228598	Saratov		Russian Federation	410028
50	Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 226222	Saratov		Russian Federation	410028
51	Psychiatric hospital #1 /ID# 226516	St. Petersburg		Russian Federation	190121
52	National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 226515	St. Petersburg		Russian Federation	192019