[ANSWERED] Recommend one FDA-approved drug, one off-label drug, and

Recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating your assigned disorder in children and adolescents

Recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating your assigned disorder in children and adolescents

Assignment 1: 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.


Agency for Healthcare Research and Quality. (2015). Off-label drugs: What you need to know. https://www.ahrq.gov/patients-consumers/patient-involvement/off-label-drug-usage.html

To Prepare

• Your Instructor will assign a specific disorder for you to research for this Assignment.

Persistent Depressive Disorder

• Use the Walden library to research evidence-based treatments for your assigned disorder in children and adolescents. 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 (1–2 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.

By Day 7 of Week 3

Submit your Assignment.

Answer and Explanation

Special Considerations Related to Prescribing for Children and Adolescents

Anxiety disorder is a psychiatric health condition under the category of mood disorders. It is a condition characterized by intense panic and worries, even during usually day-to-day events. The CDC estimates that 9.4% of children aged 3-17 years, roughly 6 million children have some form of anxiety disorder (CDC, 2021). This post will evaluate the available treatment options for anxiety disorder, the risk assessment for the FDA-approved drug, and the clinical practice guidelines for the condition

FDA-Approved Medication

Treatment of anxiety disorder in children needs special consideration, given the nature of medication and attached side effects. Selective serotonin reuptake inhibitors (SSRI) are the first-line medication for anxiety disorders among children. One of the SSRIs that can be used to treat anxiety disorders is Escitalopram. In a study by Strawn et al. (2020), the researchers found that Escitalopram is effective in reducing anxiety disorder symptoms in adolescents and is well tolerated.

Other than SSRIs, there are other classes of medication that are off-label but still effective in treating anxiety disorder. One of the off-label medications that can be used to treat anxiety disorder is Gabapentin. This is a drug that is usually used to treat patients who have depression with anxiety and bipolar (which is quite a common occurrence). In a study by Markota and Morgan (2017), there was a positive response pattern of gabapentin on anxiety disorder.  Another article by Ahmed et al. (2019) also supported the same findings.

Pharmacological approaches are usually more effective when combined with other behavioral interventions. One of the effective nonpharmacologic approaches is the use of cognitive behavioral therapy (CBT) to assist the patient in coping with situations that cause anxiety. CBT such as cognitive restructuring has been found effective in reducing the symptoms attached to anxiety disorder (Carpenter et al., 2018).

Risk Assessment

One of the risk assessments that I would conduct to inform the treatment plan for a child with anxiety disorder is a suicide risk assessment. Some of the medications that help relieve the symptoms attached to anxiety disorder have suicide ideation as one of the side effects. As such more tolerable medication should be given priority. One of the benefits attached to Escitalopram is that is well tolerated.

However, its risk is that it has certain side effects that may affect an individual functioning like insomnia, lethargy, and headaches. One of the risks of using gabapentin is that it may not be as effective as an SSRI medication and, at the same time, can result in mood changes, sleepiness, nausea, and swelling o the arms and legs.

Clinical Practice Guidelines for Anxiety Disorder

According to Gautam et al. (2017), patients should be placed on medication for 6 to 12 months. Therefore, one should consider how the side effects will impact the patient in the long run before prescribing a medication. Additionally, Gautam et al. (2017) recommend the combination of both pharmacological approaches and physiotherapeutic approaches to further improve patient outcomes. This is also a way of reducing overdependence on psychopharmacological treatment.


Various treatment modalities can be used to help children and adolescents with anxiety disorder, some of which include SSRI medication, benzodiazepines, psychotherapy, and prescription of off-label drugs. It is important to assess the efficacy of the treatment by comparing it with the side effects to guide which direction one should take when providing a treatment plan.


Ahmed, S., Bachu, R., Kotapati, P., Adnan, M., Ahmed, R., Farooq, U., Saeed, H., Khan, A. M., Zubair, A., Qamar, I., & Begum, G. (2019). Use of Gabapentin in the Treatment of Substance Use and Psychiatric Disorders: A Systematic Review. Frontiers in Psychiatry10, 228. https://doi.org/10.3389/fpsyt.2019.00228

Carpenter, J. K., Andrews, L. A., Witcraft, S. M., Powers, M. B., Smits, J., & Hofmann, S. G. (2018). Cognitive behavioral therapy for anxiety and related disorders: A meta-analysis of randomized placebo-controlled trials. Depression and Anxiety35(6), 502–514. https://doi.org/10.1002/da.22728

Centers for Disease Control and Prevention. (2021). Anxiety and depression in children: Get the facts.

Gautam, S., Jain, A., Gautam, M., Vahia, V. N., & Gautam, A. (2017). Clinical Practice Guidelines for the Management of Generalised Anxiety Disorder (GAD) and Panic Disorder (PD). Indian Journal of Psychiatry59(Suppl 1), S67–S73. https://doi.org/10.4103/0019-5545.196975

Markota, M., & Morgan, R. J. (2017). Treatment of Generalized Anxiety Disorder with Gabapentin. Case reports in psychiatry2017, 6045017. https://doi.org/10.1155/2017/6045017

Strawn, J. R., Mills, J. A., Schroeder, H., Mossman, S. A., Varney, S. T., Ramsey, L. B., Poweleit, E. A., Desta, Z., Cecil, K., & DelBello, M. P. (2020). Escitalopram in Adolescents with Generalized Anxiety Disorder: A Double-Blind, Randomized, Placebo-Controlled Study. Journal of Clinical Psychiatry81(5), 4–11. https://doi.org/10.4088/jcp.20m13396

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