NURS 6630 Week 2 Assignment

Treating Depression with Suicidality in Paediatrics Using Appropriate Medications: The Case of an 8-Year-Old African American Boy

The most authoritative and reliable diagnostic tool in psychiatry is the DSM-5 which is currently in its fifth edition. It is the Diagnostic and Statistical Manual of Mental Disorders. It classifies depression (major depressive disorder or MDD to be precise) under the broad diagnostic category of ‘Depressive Disorders’. The category also includes conditions such as dysthymia or persistent depressive disorder. Together with MDD, dysthymia presents with characteristic sadness, emptiness, and irritability (Sadock et al., 2015; APA, 2013). The case study is about an African American male child brought by his mother and who presents with sadness, thoughts about death, and a Children’s depression Rating Scale (CDRS) score of 30. Even without the symptoms, this CDRS score alone indicates that the boy is suffering from significant depression. From the history, it is clear that the boy avoids his peers in school and keeps to himself. He has complained of feeling sad, a sign that he may be experiencing anhedonia or indifference to happiness. The mental status examination or MSE also shows that the boy has suicidal thoughts (thoughts about death) as well as affect that is blunt. Considered in their totality, these symptoms align very well with the diagnosis of major depressive disorder (MDD) as outlined in the DSM-5 (APA, 2013). There are no other abnormalities found in the boy through laboratory investigations and physical examination. For this reason, the occurrence of the symptoms cannot be directly attributable to any physical illness or the effects of a substance or medication. DSM-5 criteria for diagnosing MDD include a lack of concentration, suicidal thoughts or thoughts about dying and death, prolonged sadness, a loss of interest in normal daily activities, feeling that one has no value, and psychomotor retardation (APA, 2013). This is a paper about the appropriate use of medications in treating this pediatric depression case.NURS 6630 Week 2 Assignment

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Decision Point One

At this decision point one; the decision taken is to give the 8 year-old boy with depression the selective serotonin reuptake inhibitor (SSRI) known as sertraline or Zoloft. This is an atypical antidepressant that happens to be effective against pediatric depression but that is only FDA-approved for use in treating the disorder in adults. What the FDA approval means is that there is still no safety and efficacy data from randomized controlled trials in children. However, clinicians still use such medications legally by reducing the dosages to fit the pediatric profile of their young patients. This is called off-label prescription (Allen et al., 2018; Vijay et al., 2018; Mir & Geer, 2017). In the case of Zoloft, there is enough anecdotal evidence that it is indeed effective in treating depression in children too when used off-label. The drug was started at an initial dose of 25 mg per day orally (Rosenthal & Burchum, 2018; Stahl, 2017). The child will then be monitored very closely for any signs of toxicity and adverse reactions that may occur. This is considering that information on these parameters is nonexistent for this medication in children. In other words, the information cannot be found in the package insert of medication literature that accompanies the medication (it is off-label in pediatrics).

The choice of sertraline is informed by several considerations. These are some of the reasons why a clinician may resort to off-label medications to treat pediatric conditions. Two of these stand out. The first one is when the child’s life is at risk and the physician or clinician thinks that they may benefit faster from the use of the off-label medication based on their personal experience and judgement. In this case, the African American boy has admitted to having thoughts about death and dying. This could be interpreted as suicidal ideation which places his life at risk. The second reason for using off-label medications in pediatric conditions is when there are not enough efficacious FDA-approved drugs to treat a pediatric condition. If the clinician feels that the child may then benefit from an off-label drug they have used before, they may then go ahead and use it in the spirit of beneficence as a bioethical principle (Haswell, 2019). Use of the off-label drug sertraline is therefore informed by the need to benefit the child far outweighing the risks.NURS 6630 Week 2 Assignment

The decision to choose sertraline (Zoloft) instead of the other two options (paroxetine or Paxil and bupropion or Wellbutrin) was informed by evidence-based practice (EBP). From the clinician’s experience and discussions with colleagues, sertraline has proved efficacious before when used off-label to treat pediatric major depressive disorder (Chon et al., 2017). The efficacy demonstrated by the off-label sertraline is such that remission of symptoms can be achieved within a matter of just four weeks. The hope when choosing sertraline or Zoloft was that remission of the boy’s symptoms would be achieved quickly. A confirmation of this would be made by patient testimony and repeat assessment using the CDRS (Shanahan et al., 1987). The child is expected to score lower than the initial 30 points that indicated major or significant depression.

A for the ethical considerations, the fact that the sertraline is off-label means that there is a real risk of unknown adverse effects affecting the child. However, the benefits to be gained by the child outweigh the risks and therefore it is beneficence that reigns. To mitigate the risk of harm to the patient, he will be monitored very closely and the sertraline stopped immediately there is any indication of an adverse outcome (nonmaleficence) (Haswell, 2019). These are the two bioethical principles that define the ethical perspective of this case.

Decision Point Two

On return for review and re-evaluation, the child and his mother reported that they had not experienced any improvement in the boy’s condition. In other words, the condition of depression and its symptoms remained intact even after starting the off-label sertraline (Zoloft). The boy had been taking the medication at a dose of 25 mg orally per day for the past four weeks as planned. But the absence of a change in the symptoms was not surprising at all. This lack of surprise is informed by knowledge about the pharmacodynamics of sertraline (Zoloft). Its therapeutic effect is known to start in earnest anywhere from two to four weeks (Stahl, 2017). Because of that, the boy was still well within the timeframe for the start of the therapeutic action of sertraline.

The decision taken at this decision point two was therefore to double the dose of the sertraline (Zoloft) to 50 mg orally every day for another four weeks. This decision is evidence-based as Stahl (2017) states that an increase in the dose of sertraline is indicated if the therapeutic effect does not kick in between four and six weeks. Also, increasing the dose would coincide with the beginning of the therapeutic effect and therefore maximise the benefit. The reasons for not choosing the other two options available were also evidence-based. An increase of the sertraline dose to 37.5 mg would have had minimal effect even after the therapeutic effect kicked in. Stopping sertraline and introducing fluoxetine or Prozac would have been premature and ill-informed. Even though Prozac is FDA-approved to treat MDD in children (Stahl, 2017); the off-label sertraline must first be given a chance to produce its full therapeutic effects before considering stoppage.NURS 6630 Week 2 Assignment

What was hoped would be achieved by doubling the dose of sertraline as done above was to produce a symptom reduction by about 50%, as indicated by the CDRS scores. In evidence-based practice, this is what is considered as a therapeutic response. Ethical considerations at this stage would be about autonomy. The mother and the child would be counselled and given psychoeducation so that they can remain adherent to the treatment and comply with the dosing. They will make this decision based not on coercion, but on the principle of concordance (Snowden et al., 2014). The decision by mother and child to continue with the same medication at an increased dose regardless of the apparent absence of improvement will therefore be informed (autonomy).

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Decision Point Three

The child is returned after a total of eight weeks on sertraline (Zoloft), the last four of which were at an increased dose of 50 mg per day orally. As expected, the patient and his mother report a significant reduction of in his depressive symptoms. The CDRS assessment confirms this by showing that indeed the reduction in depressive symptoms is by half (50%). Indeed, the sertraline had now begun demonstrating its therapeutic effect after four weeks of use. Because the child was obviously responding well to the off-label sertraline, the decision made at this point was to raise its dose to 75 mg orally per day. This was expected to provide sustained symptom remission in a robust way. The other two options were rejected because there was a therapeutic response already demonstrated by the use of the off-label sertraline. The hope in increasing the sertraline dose was to increase the therapeutic response by at least another 25% to 30%. Ethically, beneficence and nonmaleficence were to be upheld as on the previous occasions.

Conclusion

This case of the 8 year-old African American male child with a diagnosis of major depression is a test of the pharmacotherapeutic acumen of the clinician. A thorough knowledge is required of the pharmacodynamics of each of the agents, as is knowledge about off-label use and FDA approval. Above all, the clinician needs to be abreast of the current evidence-based practice concerning pharmacologic treatment of childhood psychiatric conditions. Major depressive disorder is a diagnosis made in both adults and children. However, treatment by FDA-approved drugs in adults is straightforward. This is not the case in pediatrics. For this reason and based on anecdotal evidence and EBP, the choice of off-label sertraline was made. Knowledge of its pharmacodynamics enabled persistence even in the face of nonresponse within the first four weeks. The reduction in depressive symptoms by 50% was the turning point in treatment. It showed that the child was demonstrating a therapeutic response. This provoked a further increase to 75 mg orally every day, which was to sustain the effect and produce an even bigger response. In all, the decisions made were the best and the treatment was a success.   NURS 6630 Week 2 Assignment

References

Allen, H.C., Garbe, M.C., Lees, J., Aziz, N., Chaaban, H., Miller, J.L., Johnson, P., & DeLeon, S. (2018). Off-label medication use in children, more common than we think: A systematic review of the literature. The Journal of the Oklahoma State Medical Association, 111(8), 776–783. https://europepmc.org/article/pmc/pmc6677268

American Psychiatric Association [APA] (2013). Diagnostic and Statistical Manual of Mental Disorders (DSM-5), 5^th ed. Author.

Chon, M-W., Lee, J., Chung, S., Kim, Y., & Kim, H-W. (2017). Prescription pattern of antidepressants for children and adolescents in Korea based on nationwide data. Journal of Korean Medical Science, 32(10), 1694-1701. https://doi.org/10.3346/jkms.2017.32.10.1694

Haswell, N. (2019). The four ethical principles and their application in aesthetic practice. Journal of Aesthetic Nursing, 8(4), 177-179. https://doi.org/10.12968/joan.2019.8.4.177

Mir, A.N. & Geer, M.I. (2017). Off-label use of medicines in children. International Journal of Pharmaceutical Sciences and Research. https://ijpsr.com/bft-article/off-label-use-of-medicines-in-children/?view=fulltext

Rosenthal, L.D., & Burchum, J.R. (2018). Lehne’s pharmacotherapeutics for nurse practitioners and physician assistants. Elsevier.

Sadock, B.J., Sadock, V.A., & Ruiz, P. (2015). Synopsis of psychiatry: Behavioral sciences clinical psychiatry, 11^th ed. Wolters Kluwer.

Shanahan, K.M., Zolkowski-Wynne, J., Coury, D.L., Collins, E.W., & O’Shea, J.S. (1987). The Children’s Depression Rating Scale for normal and depressed outpatients. Clinical Pediatrics, 26(5), 245-247. https://doi.org/10.1177/000992288702600506

Snowden, A., Martin, C., Mathers, B., & Donnell, A. (2014). Concordance: A concept analysis. Journal of Advanced Nursing, 70(1), 46-59. https://doi.org/10.1111/jan.12147

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

Vijay, A., Becker, J.E., & Ross, J.S. (2018). Patterns and predictors of off-label prescription of psychiatric drugs. PLoS ONE 13(7): e0198363. https://doi.org/10.1371/journal.pone.0198363

NURS 6630 Week 2 Assignment