Prescribing for Children and Adolescents
Bipolar disorder (BD) in children and adolescents is a chronic psychiatric disorder with multiple episodes of mood disturbance (manic and hypomanic episodes and major depressive episodes). Treatment of BD in the younger population is complex. Hence, a combination of FDA-approved medications, off-label pharmacological treatments, and non-pharmacologic interventions can be used to treat BD in the younger population. This paper addresses the evidence-based treatment options, evaluates the risks and benefits of these treatment options, and discusses the clinical practice guidelines that need to be considered in making the decision: Prescribing for Children and Adolescents.
FDA-Approved Treatment: Aripiprazole (Abilify)
Aripiprazole is FDA-approved for use in bipolar I disorder, aged 10 years and older. It acts as a dopamine D2 partial agonist and serotonin modulator by reducing the excessive activity of dopamine in manic states, as well as increasing serotonin transmission to stabilize mood in depressive symptoms (Sikander et al., 2025).
Risk and Benefit Assessment
The most significant advantage of this atypical antipsychotic is its efficacy in controlling manic and mixed episodes with uncommon sedative and weight gain potential associated with other atypical antipsychotics. Potential risks, however, include extrapyramidal symptoms (restlessness, tremors), metabolic changes (weight gain, hyperglycemia), and elevated risk of suicidal ideation in some adolescents (Sikander et al., 2025). Because of these risks, the patients should be monitored routinely with metabolic monitoring, weight checks, and psychiatric evaluations.
Off-Label Treatment: Lamotrigine (Lamictal)
The off-label lamotrigine, an anticonvulsant and mood stabilizer, is commonly used for the treatment of bipolar depression and maintenance therapy in the adolescent population. Besag et al. (2021) state that it can suppress depressive episodes, and it is an alternative for those who have trouble with mood instability and no resulting mania.
Risk and Benefit Assessment
Lamotrigine is well tolerated. However, metabolic side effects are not great. Stevens-Johnson syndrome (SJS) is its greatest danger — a rare, potentially deadly skin condition. Lamotrigine has to be titrated slowly over many weeks to combat this.
Nevertheless, it can also have other side effects, including dizziness, headaches, and gastrointestinal discomfort (Besag et al., 2021). Lamotrigine may have risks, but it is an effective off-label drug for treating bipolar depression. Overall, lamotrigine is the best drug for long-term maintenance therapy as it helps manage both bipolar disorder and minimizes weight gain and has a low sedation risk as it prevents depressive episodes.
Nonpharmacological Intervention: Cognitive Behavioral Therapy (CBT)
Considered an established intervention, Cognitive behavioral therapy (CBT) is applied to pediatric bipolar disorder. According to Nakao et al. (2021), it is designed to help identify and reconstruct maladaptive thinking patterns, control emotions, and use coping mechanisms to prevent relapse as far as possible.
Risk and Benefit Assessment
The biggest advantage of using CBT is that it is a long-term approach to symptoms with no added disadvantage of taking medication. According to Nakao et al. (2021), it is highly valuable as a means of preventing relapse and enhancing adherence to pharmacological treatment. Nevertheless, many young patients with acute mood episodes may be unable to participate actively in CBT.
Risk Assessment and Clinical Guidelines
Treatment assessment for pediatric BD should involve disease severity, adherence, side effects, and coexistent conditions. The American Academy of Child and Adolescent Psychiatry (AACAP) recommends aripiprazole, an atypical antipsychotic that is the first-line treatment for acute mania and supports psychotherapy as adjunctive to pharmacotherapy. The use of lamotrigine in children is not explicitly recommended, but lamotrigine is frequently used in adolescent bipolar depression on the basis of available clinical evidence.
Conclusion
Treatment of pediatric bipolar disorder must be comprehensive and individualized. FDA-approved aripiprazole is an effective treatment option for manic symptoms, lamotrigine can be an off-label choice for bipolar depression, and CBT is an effective nonpharmacological intervention for bipolar disorder. Clinicians can optimize treatment outcomes while minimizing risk by integrating pharmacological and nonpharmacological interventions.
References
Besag, F. M. C., Vasey, M. J., Sharma, A. N., & Lam, I. C. H. (2021). Efficacy and safety of lamotrigine in the treatment of bipolar disorder across the lifespan: A systematic review. Therapeutic Advances in Psychopharmacology, 11, 204512532110458. https://doi.org/10.1177/20451253211045870
Nakao, M., Shirotsuki, K., & Sugaya, N. (2021). Cognitive–behavioral therapy for management of mental health and stress-related disorders: Recent advances in techniques and technologies. BioPsychoSocial Medicine, 15(1), 1–4. https://doi.org/10.1186/s13030-021-00219-w
Sikander, M., Tulain, U. R., Malik, N. S., Mahmood, A., Alqahtani, M. S., Erum, A., & Khan, M. T. (2025). An approach to enhance the solubility of an atypical antipsychotic drug, aripiprazole: Design, characterization, and evaluation of arabinoxylan-based nanoparticles. Nanotechnology, Science and Applications, 18, 115–137. https://doi.org/10.2147/NSA.S502002
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Question 
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.
Reference:
- Agency for Healthcare Research and Quality. (2015). Off-label drugs: What you need to know. https://www.ahrq.gov/patients-
consumers/patient-involvement/ to an external site.off-label-drug-usage.htmlLinks 
Prescribing for Children and Adolescents
To Prepare
- Your Instructor will assign a specific disorder for you to research for this Assignment.
- 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.
submission information
Before submitting your final assignment, you can check your draft for authenticity. To check your draft, access the Turnitin Drafts from the Start Here area.
- To submit your completed assignment, save your Assignment as WK3Assgn1+last name+first initial.
- Then, click on Start Assignment near the top of the page.
- Next, click on Upload File and select Submit Assignment for review.
Resources;
- American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.)
- Wheeler, K. (Ed.). (2020). Psychotherapy for the advanced practice psychiatric nurse: A how-to guide for evidence-based practice (3rd ed.). Springer Publishing.