Assessing Cariprazine for Treating Depression in Teens with Bipolar I Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Advanced Research Center /ID# 227073
  Anaheim, California, United States Recruiting
• Inland Pyschiatric Medical Group - Chino /ID# 278667
  Chino, California, United States Recruiting
• Accellacare - Long Beach /ID# 279482
  Long Beach, California, United States Recruiting
• CHOC Children's Hospital /ID# 260298
  Orange, California, United States Recruiting
• Inland Psychiatric Medical Group /ID# 274621
  Redlands, California, United States Recruiting
• University of California Davis Health /ID# 268306
  Sacramento, California, United States Recruiting

+31 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.