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Psychotropic medications are used to treat a range of mental disorders in children and adults. Most psychotropic medications for children and adolescents are prescribed as off-label drugs<\/a> because of the limited availability of studies with children and adolescents. Off-label medications are either approved for treating another condition other than the one prescribed for or approved for a different age group. One of the conditions in children that mostly calls for off-label psychotropic prescription is a major depressive disorder. The optimal treatment for major depressive disorder in children and adolescents is a combination of psychotherapy and pharmacology\u00a0(Mullen, 2018). The important factors to consider in the choice of treatment are the safety and efficacy of the medication or nonpharmacological model chosen. The purpose of this assignment is to describe the FDA-approved medication, off-label drug, and nonpharmacological treatment approaches for major depressive disorder<\/a> in children and adolescents.<\/p>\n The FDA-approved drug for the treatment of major depressive disorder in children and adolescents is Prozac also known as fluoxetine. Fluoxetine belongs to the class selective serotonin reuptake inhibitor (SSRI). SSRIs relieve the symptoms of moderate or major depression by blocking the reabsorption of serotonin into the neurons, allowing high levels of the neurotransmitter into the brain to transmit signals between the brain and the nerves (Neavin et al., 2018). Nevertheless, the drug is only approved for children from 8 years and above. Below 8 years, the medication is used off-label based on a thorough risk versus benefits analysis. The off-label medication often prescribed for major depressive disorder in children and adolescents is Zoloft (Sertraline), which is one of the first-line antidepressants for the treatment of mood disorders. Finally, the nonpharmacological intervention for major depressive disorder in children and adolescents is cognitive behavioral therapy (CBT). CBT is an evidence-based psychotherapy model that focuses on changing thoughts and behavior from maladaptive to positive thought patterns. The strength of CBT is its effectiveness with various populations and a wide range of mental health disorders (Walter et al., 2021).<\/p>\n Risk assessment<\/a> is a critical requirement before prescribing medication. The medication prescribed to a child or adolescent should<\/p>\n have maximum therapeutic benefits and safety. When making drug choices for patients, considering individual factors is essential. For instance, the age and weight of the child matters when making prescribing decisions. For example, since off-label drugs do not have dosage details for disorders or age-group they are not approved for; hence, a practitioner relies on the weight of the child to determine the dose that would produce the desired efficacy and remain safe for the patient (van der Zanden, 2021). The assessment focuses on efficacy, safety, tolerability, possible side effects, and potential benefit to the patient. The benefits of FDA-approved medicines are established efficacy and safety backed by evidence. The risks are that the medication might not work as intended or produce unexpected problems. The risks of off-label are that the medication can cause or be ineffective owing to a lack of evidence supporting its efficacy for conditions and groups other than the approved ones\u00a0(van der Zanden, 2021).<\/p>\n The American Psychological Association, the American College of Adolescent and Child Psychiatry, and the American Academy of Pediatrics provide practice guidelines for major depressive disorder in children and adolescents. The guidelines recommend the use of CBT and other psychotherapies in combination with SSRIs as the intervention approach for children and adolescents with major depressive disorder\u00a0(Walter & Abright, 2022). The guidelines also show that treatment decisions are based on the best available evidence.<\/p>\n Off-label medications are often used within the pediatric population to treat various conditions including psychotic disorders. A risk versus benefit assessment is necessary to determine the safety and efficacy. FDA-approved medications are backed by evidence proving their safety and efficacy, but the risk is that sometimes the medication may fail to work. Off-label medications address a need but put patients at risk of harm and ineffectiveness.<\/p>\n <\/p>\n Mullen, S. (2018). Major depressive disorder in children and adolescents. . Mental Health Clinic<\/em>, 8(6), 275-283. https:\/\/doi.10.9740\/mhc.2018.11.275.<\/p>\n Neavin, D., Joyce, J., & Swintak, C. (2018). Treatment of Major Depressive Disorder in Pediatric Populations. Diseases<\/em>, 6(2):48. https:\/\/doi.10.3390\/diseases6020048.<\/p>\n van der Zanden, T. (2021). Benefit-Risk Assessment of Off-Label Drug Use in Children: The Bravo Framework. Clinical Pharmacology and Therapeutics<\/em>, 110(4), 952-965. https:\/\/doi.org\/10.1002\/cpt.2336.<\/a><\/p>\n Walter, D., Buschsieweke, J., & Dachs, L. (2021). Effectiveness of usual-care cognitive-behavioral therapy for adolescents with depressive disorders rated by parents and patients \u2013 an observational study. BMC Psychiatry<\/em>, 21, 423. https:\/\/doi.org\/10.1186\/s12888-021-03404-x.<\/a><\/p>\n Walter, H. J., & Abright, R. (2022). Clinical Practice Guideline for the Assessment and Treatment of Children and Adolescents With Major and Persistent Depressive Disorders. Journal of American Academy of Adolescents and Child Psychiatry<\/em>, https:\/\/doi.org\/10.1016\/j.jaac.2022.10.001.<\/a><\/p>\n As we begin this session, I would like to take this opportunity to clarify my expectations for this course:<\/p>\n Please note that GCU Online weeks run from Thursday (Day 1) through Wednesday (Day 7).<\/p>\n <\/p>\n Course Room Etiquette<\/strong>:<\/p>\n <\/p>\n Office Hours:<\/em><\/p>\n <\/p>\n Late Policy and Grading Policy<\/em><\/p>\n Discussion questions:<\/p>\n Assignments:<\/em><\/p>\n Participation<\/em><\/p>\n Plagiarism<\/em><\/p>\n Plagiarism includes<\/em>:<\/p>\n LopesWrite<\/em><\/p>\n Assignment Submissions<\/em><\/p>\n Grade of Incomplete<\/em><\/p>\n Grade Disputes<\/em><\/p>\n NRNP 6665 PMHNP Across the Lifespan I Prescribing for Children and Adolescents NRNP 6665 PMHNP Across the Lifespan I Prescribing for Children and Adolescents Prescribing for Children and Adolescents Psychotropic medications are used to treat a range of mental disorders in children and adults. Most psychotropic medications for children and adolescents are prescribed as off-label […]<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-114272","post","type-post","status-publish","format-standard","hentry","category-nursing-papers"],"blocksy_meta":[],"yoast_head":"\nFDA-approved and Off-label Medications<\/strong><\/h3>\n
Click here to ORDER an A++ paper from our Verified MASTERS and DOCTORATE WRITERS: NRNP 6665 PMHNP Across the Lifespan I Prescribing for Children and Adolescents<\/strong><\/a><\/em><\/span><\/h3>\n
Risk Assessment and Practice Guidelines<\/strong><\/h3>\n
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NRNP 6665 PMHNP Across the Lifespan I Prescribing for Children and Adolescents References<\/strong><\/h3>\n
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