Home › Trials › NCT04777357

Assessing Cariprazine for Treating Depression in Teens with Bipolar I Disorder

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

PHASE3 · AbbVie · NCT04777357

This study is testing if a medication called cariprazine can help teenagers with bipolar I disorder feel better during depressive episodes.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment380 (estimated)
Ages10 Years to 17 Years
SexAll
SponsorAbbVie (industry)
Locations81 sites (Bentonville, Arkansas and 80 other locations)
Trial IDNCT04777357 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of cariprazine in treating depressive episodes in pediatric patients aged 10 to 17 with bipolar I disorder. Participants will be randomly assigned to receive either cariprazine or a placebo, with the aim of measuring changes in disease activity and any adverse events. The study addresses a significant gap in treatment options for this age group, as previous research has primarily focused on adults. By utilizing established diagnostic criteria and rating scales, the trial seeks to provide robust data on the drug's impact on depressive symptoms.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged 10 to 17 with a confirmed diagnosis of bipolar I disorder experiencing a current depressive episode lasting more than 2 weeks.

Not a fit: Patients with other psychiatric disorders such as schizophrenia or PTSD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for pediatric patients suffering from depressive episodes associated with bipolar I disorder.

How similar studies have performed: While cariprazine has been studied in adults, this specific approach for pediatric patients is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion 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).

Where this trial is running

Bentonville, Arkansas and 80 other locations

+31 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Depression, Bipolar I Disorder, RGH-188, Vraylar, Cariprazine

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.