From the Guidelines
No, Rexulti (brexpiprazole) is not approved for the treatment of major depressive disorder in pediatric populations. Currently, Rexulti is FDA-approved only for adults as an adjunctive therapy to antidepressants for major depressive disorder and for the treatment of schizophrenia in adults and adolescents aged 13 years and older 1. For pediatric depression, clinicians typically consider FDA-approved options like fluoxetine (approved for ages 8 and up) or escitalopram (approved for ages 12 and up) 1. The lack of approval for Rexulti in pediatric depression reflects insufficient clinical trial data demonstrating safety and efficacy in this population. Children and adolescents often respond differently to psychotropic medications than adults, with potentially different side effect profiles and efficacy outcomes. Using medications off-label in pediatric populations requires careful consideration of risk-benefit ratios, as developing brains may be more vulnerable to certain medication effects. Any consideration of Rexulti for pediatric depression would be an off-label use requiring thorough discussion of potential risks and benefits.
Some key points to consider when treating pediatric depression include:
- Monitoring for the emergence of adverse events during antidepressant treatment (SSRIs) is crucial, as recommended by the FDA 1
- Regular and frequent monitoring schedules should be developed, taking care to obtain input from the adolescents and families to ensure compliance with the monitoring strategy 1
- Medication maintenance after response is important, and longer medication continuation periods, possibly 1 year, may be necessary for relapse prevention 1
- Close follow-up should be encouraged for at least 2 to 3 months after discontinuing medication 1
It's essential to prioritize the safety and efficacy of treatments for pediatric depression, and Rexulti is not a recommended option due to the lack of approval and clinical trial data in this population.
From the FDA Drug Label
The safety and effectiveness of brexpiprazole for treatment of major depressive disorder have not been established in pediatric patients. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning, Warnings and Precautions (5. 2)]. The safety and effectiveness of brexpiprazole have not been established in pediatric patients with MDD [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)].
Rexulti (brexpiprazole) is not approved for the treatment of major depressive disorder in pediatric populations 2 2.
From the Research
Rexulti Approval for Major Depressive Disorder in Children
- There is no direct evidence from the provided studies that Rexulti (brexpiprazole) is approved for the treatment of major depressive disorder in pediatric populations 3, 4.
- The studies primarily discuss the treatment of major depressive disorder in children and adolescents with selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants, but do not mention brexpiprazole 3, 4.
- Brexpiprazole has been approved for use as an adjunctive treatment of major depressive disorder (MDD) in adults, as well as for the treatment of schizophrenia 5, 6.
- However, none of the provided studies specifically address the approval or use of brexpiprazole in pediatric populations for major depressive disorder.
- Additional research would be needed to determine the safety and efficacy of brexpiprazole in children with major depressive disorder.