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.

Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04777357
• Other study ID #: 3112-301-001
• Secondary ID: 2020-004758-32
• Status: Recruiting
• Phase: Phase 3
• Start date: April 28, 2021
• Est. completion date: March 10, 2027

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: March 10, 2027
• Est. primary completion date: March 10, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bipolar I Disorder
• Depression

Intervention

Drug:
• Cariprazine
Oral Capsule
• Placebo
Oral Capsule

Locations

Country	Name	City	State
Puerto Rico	Dr. Samuel Sanchez PSC /ID# 245952	Caguas
Puerto Rico	GCM Medical Group PSC /ID# 245951	San Juan
Russian Federation	Clinica of Glazunova /ID# 229416	Krasnodar	Krasnodarskiy Kray
Russian Federation	Central Clinical Psychiatric Hospital /ID# 226381	Moscow
Russian Federation	Scientific Centre of Personalized Medicine /ID# 226380	Moscow
Russian Federation	Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226	Nizhny Novgorod
Russian Federation	Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462	Orenburg
Russian Federation	Medgard Clinic /ID# 228598	Saratov
Russian Federation	Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 226222	Saratov
Russian Federation	National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 226515	St. Petersburg
Russian Federation	Psychiatric hospital #1 /ID# 226516	St. Petersburg
Russian Federation	Psychotherapeutics Center Podderzhka /ID# 226348	Stavropol	Stavropol Skiy Kray
United States	Advanced Research Center /ID# 227073	Anaheim	California
United States	Atlanta Center for Medical Research /ID# 226480	Atlanta	Georgia
United States	BioBehavioral Research of Austin /ID# 227076	Austin	Texas
United States	Quest Therapeutics of Avon Lake /ID# 226349	Avon Lake	Ohio
United States	The Kennedy Krieger Institute /ID# 226509	Baltimore	Maryland
United States	Pillar Clinical Research /ID# 226504	Bentonville	Arkansas
United States	Care Access Research /ID# 226316	Beverly Hills	California
United States	UB Department of Psychiatry /ID# 226373	Buffalo	New York
United States	Ascension St. Elizabeth /ID# 240772	Chicago	Illinois
United States	University of Cincinnati /ID# 226465	Cincinnati	Ohio
United States	ProScience Research Group /ID# 226223	Culver City	California
United States	Relaro Medical Trials /ID# 227156	Dallas	Texas
United States	CenExcel iResearch LLC /ID# 228695	Decatur	Georgia
United States	D&H Doral Research Center-Doral /ID# 255458	Doral	Florida
United States	Atlanta Behavioral Research, LLC /ID# 226486	Dunwoody	Georgia
United States	Core Clinical Research /ID# 226374	Everett	Washington
United States	Earle Research /ID# 253782	Friendswood	Texas
United States	National Institute of Clinical Research - Garden Grove /ID# 262835	Garden Grove	California
United States	Advanced Research Institute of Miami /ID# 228222	Homestead	Florida
United States	McGovern Medical School /ID# 240779	Houston	Texas
United States	Red Oak Psychiatry Associates /ID# 240776	Houston	Texas
United States	Southwest Biomed Research Center LLC /ID# 226340	Houston	Texas
United States	Med Clinical Research Partners LLC /ID# 240773	Irvington	New Jersey
United States	New Dawn Psychiatric Services PLLC /ID# 229782	Kinston	North Carolina
United States	Duplicate_Alliance for Research - Long Beach /ID# 226522	Long Beach	California
United States	Columbus Clinical Services, Llc /Id# 229792	Miami	Florida
United States	Florida Research Center, Inc. /ID# 240775	Miami	Florida
United States	G+C Research Group, LLC /ID# 261399	Miami	Florida
United States	South Florida Research Ph I-IV /ID# 240778	Miami Springs	Florida
United States	NeuroCognitive and Behavioral Institute, Inc /ID# 227077	Mount Arlington	New Jersey
United States	Baber Research Group /ID# 232279	Naperville	Illinois
United States	Cutting Edge Research Group /ID# 240777	Oklahoma City	Oklahoma
United States	IPS Research Company /ID# 227072	Oklahoma City	Oklahoma
United States	Paradigm Research Professionals /ID# 260719	Oklahoma City	Oklahoma
United States	Sooner Clinical Research /ID# 226384	Oklahoma City	Oklahoma
United States	SP Research, PLLC /ID# 259428	Oklahoma City	Oklahoma
United States	ATP Clinical Research- Orange /ID# 253719	Orange	California
United States	CHOC Children's Hospital /ID# 260298	Orange	California
United States	Medical Research Group of Central Florida /ID# 256757	Orange City	Florida
United States	APG Research, LLC /ID# 226519	Orlando	Florida
United States	AIM Trials /ID# 226367	Plano	Texas
United States	Prospective Research Innovations Inc /ID# 240774	Rancho Cucamonga	California
United States	Perceptive Pharma Research /ID# 262219	Richmond	Texas
United States	University of California, San Diego Department of Psychiatry /ID# 226463	San Diego	California
United States	Benchmark Research /ID# 260714	Shreveport	Louisiana
United States	Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371	Stockbridge	Georgia
United States	D&H Tamarac Research Center /ID# 250434	Tamarac	Florida
United States	University of South Florida- Neuroscience Institute /ID# 246508	Tampa	Florida
United States	Family Psychiatry of The Woodlands /ID# 226290	The Woodlands	Texas
United States	Pacific Clinical Research Management Group /ID# 227075	Upland	California
United States	CincyScience /ID# 226318	West Chester	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Puerto Rico,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.	Baseline (Week 0) to Week 6
Primary	Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)	AIMS assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. The first 10 items are rated on a none (0) to severe (4) scale. There are an additional 2 items on dental status that are answered yes or no.	Baseline (Week 0) to Week 6
Primary	Change From Baseline in Barnes Akathisia Rating Scale (BARS)	BARS is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia (each on a 4-point scale from normal [0] to severe [3]). In addition, there is a global severity for akathisia rated on a 6-point scale (absent [0] to severe akathisia [5]).	Baseline (Week 0) to Week 6
Primary	Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)	The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.	Baseline (Week 0) to Week 10
Primary	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
Primary	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
Primary	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
Primary	Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score	The CDRS-R is a 17-item clinician-administered scale specifically developed for the assessment of depressive symptoms in children and adolescents. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. The CDRS-R will be administered by a clinician with extensive professional training in mental illness.	Baseline (Week 0) to Week 6

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