Major Depressive disorder in older adults or pregnant women 

Recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating Major Depressive disorder in older adults or pregnant women. 

FDA- approved Drug 

SSRI – Vortioxetine (Trintellix) 

In September 2013, the FDA approved vortioxetine (Brintellix) for the treatment of major depressive disorder in adults. The drug’s mechanism of action involves enhancement of serotonergic activity through 5-HT reuptake inhibition. It also modulates serotonin receptor activity through 5-HT1A receptor agonism and 5-HT3 receptor antagonism, although the contribution of these activities to the antidepressant effect is not fully understood (Center for Drug Evaluation and Research, n.d.).

Off- label drug 

St. John’s wort (Hypericum perforatum) is an herbal remedy available over the counter. Although St. John’s wort is considered a first-line antidepressant in many European countries, it has only recently gained popularity in the United States (Johnson & Shadiack, 2018). The Food and Drug Administration (FDA), however, has not approved the substance for depression or any other medical condition (Johnson & Shadiack, 2018). The FDA, in fact, classifies St. John’s wort as a dietary supplement, not a drug. Therefore, the agency doesn’t test it for safety and effectiveness. St. John’s wort may act as an SSRI.  

Non-pharmacological intervention 

Cognitive-behavioral therapy (CBT) is directed and time limited, usually involving between 10 and 20 treatments. Cognitive therapy (CT) is the most widely practiced version of CBT for depression. There is evidence supporting the use of CBT with individuals of all ages (Chen et al., 2021). For adults, CBT is considered to be efficacious and specific for the treatment of acute depression and prior CBT is considered to be efficacious and specific for the prevention of relapse. It is particularly valuable for elderly patients, who may be more prone to problems or side effects with medications. 

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?  

When a medicine’s benefits outweigh its known risks, the FDA considers it safe enough to approve. But before using any medicine, you should think through the benefits and the risks in order to make the best choice for your patient. As PMHNP, it the medication education is most important. for example, in this case, I need to give medication education to older adults and their family or care givers. The most common adverse effects were nausea, diarrhea, dry mouth, constipation, vomiting, dizziness, and sexual dysfunction. When combined with SSRIs [selective serotonin reuptake inhibitors] and MAO [monoamine oxidase] inhibitors, it may lead to elevated blood pressure and could induce what is known as serotonin syndrome, which includes confusion, fever, agitation, rapid heart rate, shivering, perspiration, diarrhea, and muscle spasms.  

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. 

Depression can limit an older adult’s independence and lead to poor health outcomes. It can create pain and upheaval in the family. Depression symptoms might continue for years if not treated. Most older persons can benefit from a number of effective therapies that help alleviate their depressive symptoms. Increasing the accessibility of these medicines is a critical step toward improving the quality of care for older persons (American Psychological Association, 2021). Providing EBPs for depression therapy can benefit in the following ways: 
Reducing or eliminating symptoms because of depression; Reduce the likelihood of suicide; Enhance physical health; and Lower functional disability.  

According to American Psychological Association (2021), uunderstanding older persons in terms of their cohort, or age group, is critical to creating a therapeutic connection, especially if you are much younger. Each generation can identify cultural norms or historical events that impact their problem-solving approach, family connections, and overall attitude on life. Older individuals now grew raised during a period of racial segregation. Some recall the Great Depression, while others participated in World War II. Cultural and generational differences, as well as physical changes associated with aging, may influence how you interact with older persons. Taking an interest in how older persons see the nature of their difficulties and the coping strategies they use might improve your connection with them.  


American Psychological Association. (2021). Guidelines for psychological practice with older adults. American Psychological Association. Retrieved January 27, 2022, from 

Center for Drug Evaluation and Research. (n.d.). FDA approves brand name change for antidepressant drug brintellix. U.S. Food and Drug Administration. Retrieved January 27, 2022, from 

Chen, J., He, P., Zhang, Y., Gao, Y., Qiu, Y., Li, Y., … & Wang, L. (2021). Non-pharmacological treatment for Parkinson disease patients with depression: a meta-analysis of repetitive transcranial magnetic stimulation and cognitive-behavioral treatment. International Journal of Neuroscience, 131(4), 411-424.

Johnson G., Shadiack, A., (2018). Does St. John Wort relieve symptoms of major depressive disorder in adults?, Evidence-Based Practice,21(8) – p 50 doi: 10.1097/01.EBP.0000544871.58596.d3 

U.S. Department of Health and Human Services. (n.d.). St. john’s wort and depression: In depthNational Center for Complementary and Integrative Health. Retrieved January 27, 2022, from 

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