AzTrials
AzTrials

DepressionPhase 33112 Ped BPDNCT04777357

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.

A Phase 3 study testing Cariprazine in people with Depression and Bipolar I Disorder, run by AbbVie at 81 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Depression, Bipolar I Disorder
What is being tested?
Cariprazine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
380 participants
Where
81 sitesin 3 countries
Study dates
28 Apr 2021to Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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 locations and contacts

81 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

81 sites in 3 countries

United States69 sites, 31 recruiting

  • Advanced Research Center /ID# 227073

    Anaheim, California, 92805

    Recruiting

  • Atlanta Center for Medical Research /ID# 226480

    Atlanta, Georgia, 30331

    Completed

  • BioBehavioral Research of Austin /ID# 227076

    Austin, Texas, 78759

    Completed

  • Quest Therapeutics of Avon Lake /ID# 226349

    Avon Lake, Ohio, 44012

    Completed

  • The Kennedy Krieger Institute /ID# 226509

    Baltimore, Maryland, 21205

    Completed

  • Beaumont Psychiatric Clinic /ID# 267484

    Beaumont, Texas, 77706

    Recruiting

  • Houston Clinical Trials - Bellaire /ID# 274189

    Bellaire, Texas, 77401

    Recruiting

  • Pillar Clinical Research /ID# 226504

    Bentonville, Arkansas, 72712

    Completed

  • Care Access Research /ID# 226316

    Beverly Hills, California, 90212

    Completed

  • Pantheon Clinical Research /ID# 270879

    Bountiful, Utah, 84010

    Recruiting

  • UB Department of Psychiatry /ID# 226373

    Buffalo, New York, 14215

    Completed

  • Duplicate_Ascension St. Elizabeth /ID# 240772

    Chicago, Illinois, 60622

    Completed

  • Inland Pyschiatric Medical Group - Chino /ID# 278667

    Chino, California, 91710

    Recruiting

  • University of Cincinnati /ID# 226465

    Cincinnati, Ohio, 45219

    Completed

  • Cleveland Clinic - Cleveland /ID# 276309

    Cleveland, Ohio, 44195

    Recruiting

  • Texas Research Group /ID# 270050

    Coppell, Texas, 75019

    Recruiting

  • ProScience Research Group /ID# 226223

    Culver City, California, 90230-6632

    Completed

  • Relaro Medical Trials /ID# 227156

    Dallas, Texas, 75243

    Recruiting

  • CenExcel iResearch LLC /ID# 228695

    Decatur, Georgia, 30030

    Recruiting

  • D&H Doral Research Center-Doral /ID# 255458

    Doral, Florida, 33122

    Recruiting

  • Atlanta Behavioral Research, LLC /ID# 226486

    Dunwoody, Georgia, 30338

    Completed

  • Core Clinical Research /ID# 226374

    Everett, Washington, 98201

    Recruiting

  • Earle Research /ID# 253782

    Friendswood, Texas, 77546

    Recruiting

  • National Institute of Clinical Research - Garden Grove /ID# 262835

    Garden Grove, California, 92844

    Completed

  • Advanced Research Institute of Miami /ID# 228222

    Homestead, Florida, 33030-4613

    Completed

  • McGovern Medical School /ID# 240779

    Houston, Texas, 77054

    Completed

  • Southwest Biomed Research Center LLC /ID# 226340

    Houston, Texas, 77063

    Completed

  • Kaleidoscope Clinical Research /ID# 277650

    Houston, Texas, 77089

    Site Coordinator, 832-969-6157, sekeia.willis@sclamanagement.com

    Recruiting

  • Red Oak Psychiatry Associates /ID# 240776

    Houston, Texas, 77090-2641

    Completed

  • Indiana University /ID# 260705

    Indianapolis, Indiana, 46202-3082

    Completed

  • Med Clinical Research Partners LLC /ID# 240773

    Irvington, New Jersey, 07111

    Recruiting

  • New Dawn Psychiatric Services PLLC /ID# 229782

    Kinston, North Carolina, 28501-1603

    Completed

  • Accellacare - Long Beach /ID# 279482

    Long Beach, California, 90807

    Recruiting

  • Duplicate_Alliance for Research - Long Beach /ID# 226522

    Long Beach, California, 90807

    Completed

  • Livingspring Family Medical Center /ID# 262706

    Mansfield, Texas, 76063-5622

    Recruiting

  • Columbus Clinical Services, Llc /Id# 229792

    Miami, Florida, 33125

    Completed

  • G+C Research Group, LLC /ID# 261399

    Miami, Florida, 33126-2018

    Completed

  • Florida Research Center, Inc. /ID# 240775

    Miami, Florida, 33174

    Recruiting

  • South Florida Research Ph I-IV /ID# 240778

    Miami Springs, Florida, 33166-7225

    Completed

  • Duplicate_NeuroCognitive and Behavioral Institute, Inc /ID# 227077

    Mount Arlington, New Jersey, 07856-1315

    Completed

  • Baber Research Group /ID# 232279

    Naperville, Illinois, 60563-6502

    Completed

  • IPS Research Company /ID# 227072

    Oklahoma City, Oklahoma, 73106

    Completed

  • SP Research, PLLC /ID# 259428

    Oklahoma City, Oklahoma, 73112-8729

    Completed

  • Cutting Edge Research Group /ID# 240777

    Oklahoma City, Oklahoma, 73116-1423

    Completed

  • Paradigm Research Professionals /ID# 260719

    Oklahoma City, Oklahoma, 73116

    Completed

  • Sooner Clinical Research /ID# 226384

    Oklahoma City, Oklahoma, 73116

    Recruiting

  • CHOC Children's Hospital /ID# 260298

    Orange, California, 92868-4203

    Recruiting

  • ATP Clinical Research- Orange /ID# 253719

    Orange, California, 92868

    Completed

  • Medical Research Group of Central Florida /ID# 256757

    Orange City, Florida, 32763

    Recruiting

  • Advanced Quality Medical Research /ID# 272902

    Orland Park, Illinois, 60462

    Recruiting

  • APG Research, LLC /ID# 226519

    Orlando, Florida, 32803

    Completed

  • Nova Psychiatry Inc. /ID# 270892

    Orlando, Florida, 32803

    Recruiting

  • Panhandle Research and Medical Clinic, LLC /ID# 268522

    Pensacola, Florida, 32502

    Completed

  • Aim Trials /ID# 226367

    Plano, Texas, 75093

    Site Coordinator, 214-856-2778

    Recruiting

  • Prospective Research Innovations Inc /ID# 240774

    Rancho Cucamonga, California, 91730

    Completed

  • Inland Psychiatric Medical Group /ID# 274621

    Redlands, California, 92373

    Recruiting

  • Perceptive Pharma Research /ID# 262219

    Richmond, Texas, 77407

    Recruiting

  • University of California Davis Health /ID# 268306

    Sacramento, California, 95817

    Site Coordinator, 916-734-3574, cqthai@health.ucdavis.edu

    Recruiting

  • University of California, San Diego Department of Psychiatry /ID# 226463

    San Diego, California, 92103-8229

    Completed

  • Lumos Clinical Research Center /ID# 262805

    San Jose, California, 95124-4108

    Completed

  • Benchmark Research /ID# 260714

    Shreveport, Louisiana, 71101

    Completed

  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371

    Stockbridge, Georgia, 30281

    Completed

  • Denali Health Atlanta, LLC /ID# 278167

    Stone Mountain, Georgia, 30083

    Recruiting

  • D&H Tamarac Research Center /ID# 250434

    Tamarac, Florida, 33321-2979

    Recruiting

  • University of South Florida- Neuroscience Institute /ID# 246508

    Tampa, Florida, 33613

    Completed

  • Family Psychiatry of The Woodlands /ID# 226290

    The Woodlands, Texas, 77381

    Recruiting

  • Pacific Clinical Research Management Group /ID# 227075

    Upland, California, 91786

    Completed

  • CincyScience /ID# 226318

    West Chester, Ohio, 45069

    Recruiting

  • Next Level Clinical Trials /ID# 277152

    West Covina, California, 91790

    Site Coordinator, 773-424-2430, jemmanuella@nextleveltrials.com

    Recruiting

Other trials in United States

Russia10 sites

  • Clinica of Glazunova /ID# 229416

    Krasnodar, Krasnodarskiy Kray, 350051

    Completed

  • Duplicate_Scientific Centre of Personalized Medicine /ID# 226380

    Moscow, Moscow, 105082

    Completed

  • Duplicate_Central Clinical Psychiatric Hospital /ID# 226381

    Moscow, Moscow, 127083

    Completed

  • Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226

    Nizhny Novgorod, 603155

    Completed

  • Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462

    Orenburg, Orenburg Oblast, 460006

    Completed

  • Psychiatric hospital #1 /ID# 226516

    Saint Petersburg, 190121

    Completed

  • National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 226515

    Saint Petersburg, 192019

    Completed

  • Medgard Clinic /ID# 228598

    Saratov, 410028

    Completed

  • Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 226222

    Saratov, 410028

    Completed

  • Psychotherapeutics Center Podderzhka /ID# 226348

    Stavropol, Stavropol Kray, 355029

    Completed

Other trials in Russia

Puerto Rico2 sites, 1 recruiting

  • Dr. Samuel Sanchez PSC /ID# 245952

    Caguas, 00727

    Completed

  • GCM Medical Group /ID# 245951

    San Juan, 00917-3104

    Recruiting

Other trials in Puerto Rico

About this study

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

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.

Read more

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.

Being tested
Cariprazine, Placebo
Keywords
Depression, RGH-188, Bipolar I Disorder, Vraylar, Cariprazine
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CariprazineDrug

    Also called Vraylar

    Oral Capsule

  • PlaceboDrug

    Oral Capsule

Study groups in NCT04777357
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive Placebo over a 6 week treatment period.
Receives: Drug: Placebo
CariprazineExperimentalParticipants will receive flexible dose Cariprazine over a 6 week treatment period.
Receives: Drug: Cariprazine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Week 0) to Week 10

  2. Abnormal Change from Baseline in Vital Signs

    Change in vital signs like systolic and diastolic blood pressure will be assessed.

    Measured: Baseline (Week 0) to Week 10

  3. 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.

    Measured: Baseline (Week 0) to Week 6

  4. Change in Electrocardiogram (ECG)

    12 -lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.

    Measured: Baseline (Week 0) to Week 6

  5. 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.

    Measured: Baseline (Week 0) to Week 6

  6. 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.

    Measured: Baseline (Week 0) to Week 10

  7. 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]).

    Measured: Baseline (Week 0) to Week 6

  8. 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.

    Measured: Baseline (Week 0) to Week 6

  9. 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.

    Measured: Baseline (Week 0) to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2021
  2. Study start28 Apr 2021
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04777357
Sponsor's protocol ID
3112-301-001
Other IDs
2020-004758-32
Acronym
3112 Ped BPD
Status last verified
Jul 2026
First submitted
26 Feb 2021
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cariprazine in people with Depression and Bipolar I Disorder, run by AbbVie at 81 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Russia, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (time frame: Baseline (Week 0) to Week 10). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04777357.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
3112 Ped BPD Clinical Trial NCT04777357 | AzTrials