Off-label prescribing FOR CHILDREN AND ADOLESCENTS : NRNP-6665 WEEK 3 Assignment – assignmenthandlers

Off-label prescribing FOR CHILDREN AND ADOLESCENTS : NRNP-6665 WEEK 3 Assignment

Prescribing Medications for Children and Adolescents with Major Depressive Disorder (MDD)

Major depressive disorder, or MDD, is a depressive disorder characterized by feelings of worthlessness, suicidality, low self-esteem, depressed mood, and a lack of enjoyment of pleasurable activities that were previously enjoyed (APA, 2022). Listings are diagnostic criteria in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders or DSM-5-TR that must exist for the diagnosis. Its treatment in children and adolescents involves using pharmacotherapy and psychotherapy or other nonpharmacologic strategies (Pataki & Carlson, 2016). The pharmacologic treatment makes use of FDA-approved and non-FDA-approved (off-label) medications.

An FDA-Approved, an Off-Label, and a Nonpharmacologic Intervention for MDD

One of the FDA-approved medications for treating MDD is fluoxetine (Prozac). It is a selective serotonin reuptake inhibitor or SSRI (Stahl, 2017). It is the drug I would recommend for the treatment of MDD in children and adolescents. It is supposed to be given to children and adolescents aged eight years and above. According to Braüner et al. (2016) found that about 32.3% of all psychiatric prescriptions for children and adolescents are off-label. Sertraline (Zoloft) which is another SSRI, is the off-label medication I would recommend for treating major depression in children and adolescents.

Nonpharmacological interventions are also evidence-based, just like medications. Usually, they include psychoeducation and psychosocial treatments. A proven psychotherapeutic modality for managing MDD in children and adolescents as in adults is cognitive behavioral therapy or CBT (Shrestha et al., 2020). It encompasses the cognitive remodeling of restructuring, which is about changing the thought process.

Risk Assessment

Figuring out the effectiveness and safety of medications, particularly those not endorsed by the FDA, is a key component of the risk analysis that will be carried out to guide therapeutic results. Additionally, in-depth discussions with peers who have used it and had greater expertise are required. The risk analysis for the FDA-approved one will include assessing the likelihood of negative effects. The FDA-approved medication fluoxetine and the off-label sertraline have the advantage of being effective at treating MDD. Its risks, together with the off-label sertraline, include the possibility of agitation and insomnia, amongst other adverse effects (Stahl, 2017). These are taken into account in the risk assessment.

Clinical Practice Guidelines

There are indeed clinical practice guidelines in the management of depression. The guidelines recommend treatment with a dual approach of medications and psychotherapy (Gautam et al., 2017). In the guidelines, SSRIs are ideal because of their low side effects, effectiveness, and tolerability. Then again, CBT is preferred because of its proven effectiveness in resolving symptoms in those on medications. However, even with the guidelines prepared, treating depression, especially in children and adolescents, still requires careful critical clinical decision-making for each patient.


Major depressive disorder, or MDD, is a depressive disorder with a high morbidity and mortality rate in the general population. Its treatment can occasionally be challenging, especially in children and adolescents. However, the use of off-label prescriptions and nonpharmacologic strategies on top of FDA-approved drugs has proven effective. Available clinical practice guidelines support these recommendations Off-label prescribing FOR CHILDREN AND ADOLESCENTS : NRNP-6665 WEEK 3 Assignment .



American Psychiatric Association [APA] (2022). Diagnostic and Statistical Manual of Mental Disorders-Text Revision (DSM-5-TR), 5th ed. Author.

Braüner, J.V., Johansen, L.M., Roesbjerg, T., & Pagsberg, A.K. (2016). Off-label prescription of psychopharmacological drugs in child and adolescent psychiatry. Journal of Clinical Psychopharmacology, 36(5), 500–507.

Gautam, S., Jain, A., Gautam, M., Vahia, V.N., & Grover, S. (2017). Clinical practice guidelines for the management of depression. Indian Journal of Psychiatry, 59(Suppl. 1), S34-S50.

Pataki, C., & Carlson, G. A. (2016). Major depressive disorder among children and adolescents. FOCUS, 14(1), 10–14.

Sadock, B.J., Sadock, V.A., & Ruiz, P. (2015). Synopsis of psychiatry: Behavioral sciences clinical psychiatry, 11th ed. Wolters Kluwer. Off-label prescribing FOR CHILDREN AND ADOLESCENTS : NRNP-6665 WEEK 3 Assignment

Shrestha, M., Lautenschleger, J., & Soares, N. (2020). Non-pharmacologic management of attention-deficit/hyperactivity disorder in children and adolescents: A review. Translational Pediatrics, 9(S1), S114–S124.

Stahl, S.M. (2017). Stahl’s essential psychopharmacology: Prescriber’s guide, 6th ed. Cambridge University Press.



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