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Could a bipolar drug lift teen depression? new trial seeks answers

NCT ID NCT04777357

Symptom relief Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This study tests whether cariprazine (Vraylar) can safely ease depressive episodes in teens aged 10-17 with bipolar I disorder. Around 380 participants will receive either the drug or a placebo for 6 weeks, with dose adjustments based on response. The goal is to see if the drug improves mood and is well-tolerated in younger patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cariprazine (Vraylar)
What this could lead to
If it works, this could provide a new treatment option for depressive episodes in teens with bipolar I disorder, where options are currently limited.
What could go wrong
This is an early-stage study in a small group, and results may not apply to all teens. Side effects like movement disorders or suicidal thoughts are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 380 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

bipolar depression bipolar I disorder Depression depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar I disorder Depression

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    32 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APG Research, LLC /ID# 226519

    COMPLETED

    Orlando, Florida, 32803, United States

  • ATP Clinical Research- Orange /ID# 253719

    COMPLETED

    Orange, California, 92868, United States

  • Accellacare - Long Beach /ID# 279482

    RECRUITING

    Long Beach, California, 90807, United States

  • Advanced Quality Medical Research /ID# 272902

    RECRUITING

    Orland Park, Illinois, 60462, United States

  • Advanced Research Center /ID# 227073

    RECRUITING

    Anaheim, California, 92805, United States

  • Advanced Research Institute of Miami /ID# 228222

    COMPLETED

    Homestead, Florida, 33030-4613, United States

  • Aim Trials /ID# 226367

    RECRUITING

    Plano, Texas, 75093, United States

  • Atlanta Behavioral Research, LLC /ID# 226486

    COMPLETED

    Dunwoody, Georgia, 30338, United States

  • Atlanta Center for Medical Research /ID# 226480

    COMPLETED

    Atlanta, Georgia, 30331, United States

  • Baber Research Group /ID# 232279

    COMPLETED

    Naperville, Illinois, 60563-6502, United States

  • Beaumont Psychiatric Clinic /ID# 267484

    RECRUITING

    Beaumont, Texas, 77706, United States

  • Benchmark Research /ID# 260714

    COMPLETED

    Shreveport, Louisiana, 71101, United States

  • BioBehavioral Research of Austin /ID# 227076

    COMPLETED

    Austin, Texas, 78759, United States

  • CHOC Children's Hospital /ID# 260298

    RECRUITING

    Orange, California, 92868-4203, United States

  • Care Access Research /ID# 226316

    COMPLETED

    Beverly Hills, California, 90212, United States

  • CenExcel iResearch LLC /ID# 228695

    RECRUITING

    Decatur, Georgia, 30030, United States

  • CincyScience /ID# 226318

    RECRUITING

    West Chester, Ohio, 45069, United States

  • Cleveland Clinic - Cleveland /ID# 276309

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinica of Glazunova /ID# 229416

    COMPLETED

    Krasnodar, Krasnodarskiy Kray, 350051, Russia

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

    COMPLETED

    Nizhny Novgorod, 603155, Russia

  • Columbus Clinical Services, Llc /Id# 229792

    COMPLETED

    Miami, Florida, 33125, United States

  • Core Clinical Research /ID# 226374

    RECRUITING

    Everett, Washington, 98201, United States

  • Cutting Edge Research Group /ID# 240777

    COMPLETED

    Oklahoma City, Oklahoma, 73116-1423, United States

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

    RECRUITING

    Doral, Florida, 33122, United States

  • D&H Tamarac Research Center /ID# 250434

    RECRUITING

    Tamarac, Florida, 33321-2979, United States

  • Denali Health Atlanta, LLC /ID# 278167

    RECRUITING

    Stone Mountain, Georgia, 30083, United States

  • Dr. Samuel Sanchez PSC /ID# 245952

    COMPLETED

    Caguas, 00727, Puerto Rico

  • Duplicate_Alliance for Research - Long Beach /ID# 226522

    COMPLETED

    Long Beach, California, 90807, United States

  • Duplicate_Ascension St. Elizabeth /ID# 240772

    COMPLETED

    Chicago, Illinois, 60622, United States

  • Duplicate_Central Clinical Psychiatric Hospital /ID# 226381

    COMPLETED

    Moscow, Moscow, 127083, Russia

  • Duplicate_NeuroCognitive and Behavioral Institute, Inc /ID# 227077

    COMPLETED

    Mount Arlington, New Jersey, 07856-1315, United States

  • Duplicate_Scientific Centre of Personalized Medicine /ID# 226380

    COMPLETED

    Moscow, Moscow, 105082, Russia

  • Earle Research /ID# 253782

    RECRUITING

    Friendswood, Texas, 77546, United States

  • Family Psychiatry of The Woodlands /ID# 226290

    RECRUITING

    The Woodlands, Texas, 77381, United States

  • Florida Research Center, Inc. /ID# 240775

    RECRUITING

    Miami, Florida, 33174, United States

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

    COMPLETED

    Miami, Florida, 33126-2018, United States

  • GCM Medical Group /ID# 245951

    RECRUITING

    San Juan, 00917-3104, Puerto Rico

  • Houston Clinical Trials - Bellaire /ID# 274189

    RECRUITING

    Bellaire, Texas, 77401, United States

  • IPS Research Company /ID# 227072

    COMPLETED

    Oklahoma City, Oklahoma, 73106, United States

  • Indiana University /ID# 260705

    COMPLETED

    Indianapolis, Indiana, 46202-3082, United States

  • Inland Psychiatric Medical Group /ID# 274621

    RECRUITING

    Redlands, California, 92373, United States

  • Inland Pyschiatric Medical Group - Chino /ID# 278667

    RECRUITING

    Chino, California, 91710, United States

  • Kaleidoscope Clinical Research /ID# 277650

    RECRUITING

    Houston, Texas, 77089, United States

  • Livingspring Family Medical Center /ID# 262706

    RECRUITING

    Mansfield, Texas, 76063-5622, United States

  • Lumos Clinical Research Center /ID# 262805

    COMPLETED

    San Jose, California, 95124-4108, United States

  • McGovern Medical School /ID# 240779

    COMPLETED

    Houston, Texas, 77054, United States

  • Med Clinical Research Partners LLC /ID# 240773

    RECRUITING

    Irvington, New Jersey, 07111, United States

  • Medgard Clinic /ID# 228598

    COMPLETED

    Saratov, 410028, Russia

  • Medical Research Group of Central Florida /ID# 256757

    RECRUITING

    Orange City, Florida, 32763, United States

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

    COMPLETED

    Garden Grove, California, 92844, United States

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

    COMPLETED

    Saint Petersburg, 192019, Russia

  • New Dawn Psychiatric Services PLLC /ID# 229782

    COMPLETED

    Kinston, North Carolina, 28501-1603, United States

  • Next Level Clinical Trials /ID# 277152

    RECRUITING

    West Covina, California, 91790, United States

  • Nova Psychiatry Inc. /ID# 270892

    RECRUITING

    Orlando, Florida, 32803, United States

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

    COMPLETED

    Orenburg, Orenburg Oblast, 460006, Russia

  • Pacific Clinical Research Management Group /ID# 227075

    COMPLETED

    Upland, California, 91786, United States

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

    COMPLETED

    Pensacola, Florida, 32502, United States

  • Pantheon Clinical Research /ID# 270879

    RECRUITING

    Bountiful, Utah, 84010, United States

  • Paradigm Research Professionals /ID# 260719

    COMPLETED

    Oklahoma City, Oklahoma, 73116, United States

  • Perceptive Pharma Research /ID# 262219

    RECRUITING

    Richmond, Texas, 77407, United States

  • Pillar Clinical Research /ID# 226504

    COMPLETED

    Bentonville, Arkansas, 72712, United States

  • ProScience Research Group /ID# 226223

    COMPLETED

    Culver City, California, 90230-6632, United States

  • Prospective Research Innovations Inc /ID# 240774

    COMPLETED

    Rancho Cucamonga, California, 91730, United States

  • Psychiatric hospital #1 /ID# 226516

    COMPLETED

    Saint Petersburg, 190121, Russia

  • Psychotherapeutics Center Podderzhka /ID# 226348

    COMPLETED

    Stavropol, Stavropol Kray, 355029, Russia

  • Quest Therapeutics of Avon Lake /ID# 226349

    COMPLETED

    Avon Lake, Ohio, 44012, United States

  • Red Oak Psychiatry Associates /ID# 240776

    COMPLETED

    Houston, Texas, 77090-2641, United States

  • Relaro Medical Trials /ID# 227156

    RECRUITING

    Dallas, Texas, 75243, United States

  • SP Research, PLLC /ID# 259428

    COMPLETED

    Oklahoma City, Oklahoma, 73112-8729, United States

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

    COMPLETED

    Saratov, 410028, Russia

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

    COMPLETED

    Stockbridge, Georgia, 30281, United States

  • Sooner Clinical Research /ID# 226384

    RECRUITING

    Oklahoma City, Oklahoma, 73116, United States

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

    COMPLETED

    Miami Springs, Florida, 33166-7225, United States

  • Southwest Biomed Research Center LLC /ID# 226340

    COMPLETED

    Houston, Texas, 77063, United States

  • Texas Research Group /ID# 270050

    RECRUITING

    Coppell, Texas, 75019, United States

  • The Kennedy Krieger Institute /ID# 226509

    COMPLETED

    Baltimore, Maryland, 21205, United States

  • UB Department of Psychiatry /ID# 226373

    COMPLETED

    Buffalo, New York, 14215, United States

  • University of California Davis Health /ID# 268306

    RECRUITING

    Sacramento, California, 95817, United States

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

    COMPLETED

    San Diego, California, 92103-8229, United States

  • University of Cincinnati /ID# 226465

    COMPLETED

    Cincinnati, Ohio, 45219, United States

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

    COMPLETED

    Tampa, Florida, 33613, United States

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Other studies related to the condition(s) this trial covers.