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New treatment option for Depression
Official title 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.
ClinicalTrials.gov ID: NCT04777357
What this study is testing
What is Cariprazine?
Cariprazine is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for depression.
Also referred to as Vraylar.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 17
You may be able to join if
- Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) primary diagnosis of bipolar I disorder as confirmed...
- 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.
You likely can't join if
- Participants with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder...
- Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months...
- 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...
- History of seizures, with the exception of febrile seizures.
See the full eligibility 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...
- 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.
- Participants with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bentonville, Arkansas, United States
- Anaheim, California, United States
- Beverly Hills, California, United States
- Chino, California, United States
- Culver City, California, United States
- Garden Grove, California, United States
- Long Beach, California, United States
- Orange, California, United States
- Rancho Cucamonga, California, United States
- Redlands, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Jose, California, United States
- Upland, California, United States
- West Covina, California, United States
- Doral, Florida, United States
- Homestead, Florida, United States
- Miami, Florida, United States
- Miami Springs, Florida, United States
- Orange City, Florida, United States
+ 46 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bentonville, Arkansas, United States; Anaheim, California, United States; Beverly Hills, California, United States; Chino, California, United States; Culver City, California, United States; Garden Grove, California, United States and 60 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.