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Special Considerations Related to Prescribing for Children and Adolescents 

Off-label prescribing is when a physician gives you a drug that the U.S. Food and Drug Administration (FDA) has approved to treat a condition different than your condition. This practice is legal and common. In fact, one in five prescriptions written today are for off-label use.
Agency for Healthcare Research and Quality
Psychotropic drugs are commonly used for children and adolescents to treat mental health disorders, yet many of these drugs are not FDA approved for use in these populations. Thus, their use is considered “off-label,” and it is often up to the best judgment of the prescribing clinician. As a PMHNP, you will need to apply the best available information and research on pharmacological treatments for children in order to safely and effectively treat child and adolescent patients. Sometimes this will come in the form of formal studies and approvals for drugs in children. Other times you may need to extrapolate from research or treatment guidelines on drugs in adults. Each individual patient case will need to be considered independently and each treatment considered from a risk assessment standpoint. What psychotherapeutic approach might be indicated as an initial treatment? What are the potential side effects of a particular drug?
For this Assignment, you consider these questions and others as you explore FDA-approved (“on label”) pharmacological treatments, non-FDA-approved (“off-label”) pharmacological treatments, and nonpharmacological treatments for disorders in children and adolescents.

To Prepare
Your assigned disorder is a Childhood Onset Schizophrenia Spectrum Disorders. Research for this disorder. Treatment should be specific for children/adolescents
•    Use the evidenced scholarly library to research evidence-based treatments for your assigned  “Childhood Onset Schizophrenia Spectrum Disorders”.  You will need to recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating this disorder in children and adolescents.
The Assignment 2 pages
Recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating your assigned disorder in children and adolescents.
Explain the risk assessment you would use to inform your treatment decision making. What are the risks and benefits of the FDA-approved medicine? What are the risks and benefits of the off-label drug?
Explain whether clinical practice guidelines exist for this disorder and, if so, use them to justify your recommendations. If not, explain what information you would need to take into consideration.
Support your reasoning with at least three scholarly resources, one each on the FDA-approved drug, the off-label, and a non-medication intervention for the disorder. Attach the PDFs of your sources.

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 Special Considerations Related to Prescribing for Children and Adolescents

Though rare childhood-onset schizophrenia occurs in a significant number of children and requires immediate diagnosis and aggressive treatment. Childhood-onset schizophrenia is often severe, debilitating, and chronic. Like any other psychological disorder, treatment of childhood-onset schizophrenia can take various approaches depending on the clinician's judgment, patient factors, and analysis of risks and benefits in each patient. The treatment options include using an off-label medication, on-label medication, or nonpharmacological approach.

An off-label medication commonly used for the treatment of childhood-onset schizophrenia is Clozapine. According to a study conducted by Kasoff et al. (2016), clozapine is not only effective for the treatment of childhood-onset schizophrenia but also functions well as a long-term maintenance treatment. This is important because the longer an antipsychotic drug can be used while maintaining its safety and effectiveness, the better the efficacy of the drug. In this case, the study involved a follow-up of the patients for two years. Though the efficacy and effectiveness of the drug are evidence proven for use in children, it still presents possible adverse effects in the population given that it is not FDA approved. The potential side effects include weight gain, nausea, headache, and fever while the benefit is the ability to relieve the symptoms of schizophrenia in children, which shows more efficacy than in adult schizophrenia.

Similarly, there are several FAD-approved medications for the treatment of schizophrenia in children and adolescents for example Haloperidol, Olanzapine, Risperidone, and Lurasidone. Lurasidone is a second-generation antipsychotic medication approved for the treatment of schizophrenia in adolescents. The efficacy and effectiveness of the use of Lurasidone are supported by several studies. A study by Goldman et al. (2017) shows meaningful clinical improvement in symptoms as demonstrated by the study participants who were adolescents. The benefit of the drug is that is it well tolerated and shows efficacy and safety with the patients. For example, the study noted only minor side effects such as nausea, vomiting, and akathisia. Other side effects common with antipsychotic medications in children including loss of body weight, seizures, and hyperprolactinemia are not common with this medication (Zaim, Findling, & Sun, 2020).

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The non-pharmacological approach that I would choose for the treatment of schizophrenia in children and adolescents is supportive therapy. Supportive therapy is a psychotherapy technique that relies on the therapeutic alliance between the client and the therapist to work through issues. The therapy aims to help the child or adolescent develop self-esteem, alleviate symptoms of the condition, strengthen the capacity to deal with life stressors, restore reality, and regulate negative thinking and impulses. A study by Diamond et al. (2018) indicates the benefit of supportive therapy in reducing suicidal ideation, depressive symptoms, and other psychotic symptoms associated with onset schizophrenia. Moreover, supportive therapy shows more effectiveness in treating schizophrenia in children and adolescents than CBT.

Clinical practice guidelines exist to assist clinicians in making decisions regarding the assessment, diagnosis, and treatment of childhood-onset schizophrenia. For example, in the treatment of childhood-onset schizophrenia, the clinical guidelines support the use of second-generation antipsychotic medications (SGAMs) over the first generation because they are associated with fewer side effects. Examples of SGAMs are clozapine and Lurasidone chosen in this scenario (Grover & Avasthi, 2019). Similarly, the guidelines give psychosocial approaches such as supportive therapy as an alternative for the treatment of schizophrenia in children and children. The criteria for evaluating risks in the patients that leads to a choice of safe and effective medications according to the guidelines include side effects of the medication, patient factors, medical comorbidity, family preference, past treatment response, psychiatric comorbidity, and clinician’s familiarity with a particular medication for use in children (Grover & Avasthi, 2019).




Diamond, G., Kobak, R., Ewing, E., & Levy, S. (2018). Attachment-Based Family and Non-Directive Supportive Treatments for Suicidal Youth: A Comparative Efficacy Trial. Journal of the American Academy of Child & Adolescent Psychiatry, 58(7). DOI: 10.1016/j.jaac.2018.10.006.

Goldman, R., Loebel, A., Cucchiaro, J., Deng, L., & Findling, R. (2017). Efficacy and Safety of Lurasidone in Adolescents with Schizophrenia: A 6-Week, Randomized Placebo-Controlled Study. J Child Adolesc Psychopharmacol, 27(6): 516–525. doi: 10.1089/cap.2016.0189.

Grover, S., & Avasthi, A. (2019). Clinical Practice Guidelines for the Management of Schizophrenia in Children and Adolescents. Indian J Psychiatry. doi: 10.4103/psychiatry.IndianJPsychiatry_556_18, 61(Suppl 2): 277–293.

Kasoff, L. I., Ahn, K., Gochman, P., Broadnax, D., & Rapoport, J. (2016). Strong Treatment Response and High Maintenance Rates of Clozapine in Childhood-Onset Schizophrenia. J Child Adolesc Psychopharmacol, 26(5), 428–435. doi: 10.1089/cap.2015.0103.

Zaim, N., Findling, R., & Sun, A. (2020). Antipsychotics for Treatment of Adolescent Onset Schizophrenia: a Review. Curr Treat Options Psych, 7, 23–38.

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