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Protocol

A Double-Blind Randomized Trial to Investigate Mechanisms of Antidepressant-Related Dysfunctional Arousal in Depressed or Anxious Youth at Familial Risk for Bipolar Disorder

by
Duncan C. Honeycutt
1,
Melissa P. DelBello
1,*,
Jeffrey R. Strawn
1,
Laura B. Ramsey
2,
Luis R. Patino
1,
Kyle Hinman
3,
Jeffrey Welge
1,
David J. Miklowitz
4,
Booil Jo
3,
Thomas J. Blom
1,
Kaitlyn M. Bruns
1,
Sarah K. Hamill Skoch
1,
Nicole Starace
3,
Maxwell J. Tallman
1 and
Manpreet K. Singh
3,*
1
Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH 45267, USA
2
Deptartment of Pediatrics Research in Patient Services, Cincinnati Children’s Hospital Medical Center, Pharmacy Research, Cincinnati, OH 45229, USA
3
Department of Psychiatry and Behavioral Sciences, Stanford Medicine, Stanford, CA 94304, USA
4
Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA 90024, USA
*
Authors to whom correspondence should be addressed.
J. Pers. Med. 2022, 12(6), 1006; https://doi.org/10.3390/jpm12061006
Submission received: 27 April 2022 / Revised: 11 June 2022 / Accepted: 17 June 2022 / Published: 20 June 2022
(This article belongs to the Section Pharmacogenetics)
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Abstract

Antidepressants are standardly used to treat moderate to severe symptoms of depression and/or anxiety in youth but may also be associated with rare but serious psychiatric adverse events such as irritability, agitation, aggression, or suicidal ideation. Adverse events are especially common in youth with a family history of bipolar disorder (BD) who are at heightened risk for dysfunction in neurobiological systems that regulate emotion and arousal. To further understand this phenomenon, this study will examine (a) baseline risk factors associated with dysfunctional arousal in a sample of youth at high-risk for BD treated with or without an antidepressant, (b) whether antidepressant-related changes in arousal are mediated by changes in prefrontal-limbic circuitry, and (c) whether pharmacogenetic factors influence antidepressant-related changes in arousal. High-risk youth (aged 12–17 years with moderate to severe depressive and/or anxiety symptoms and at least one first-degree relative with bipolar I disorder) will be randomized to receive psychotherapy plus escitalopram or psychotherapy plus placebo. Neuroimaging and behavioral measures of arousal will be collected prior to randomization and at 4 weeks. Samples for pharmacogenetic analysis (serum escitalopram concentration, CYP2C19 metabolizer phenotype, and HTR2A and SLC6A4 genotypes) will be collected at 8 weeks. Youth will be followed for up to 16 weeks to assess change in arousal measures.
Keywords: bipolar risk; hyperarousal; depression; anxiety; adolescent; neuroimaging; escitalopram; pharmacogenetics bipolar risk; hyperarousal; depression; anxiety; adolescent; neuroimaging; escitalopram; pharmacogenetics

Share and Cite

MDPI and ACS Style

Honeycutt, D.C.; DelBello, M.P.; Strawn, J.R.; Ramsey, L.B.; Patino, L.R.; Hinman, K.; Welge, J.; Miklowitz, D.J.; Jo, B.; Blom, T.J.; et al. A Double-Blind Randomized Trial to Investigate Mechanisms of Antidepressant-Related Dysfunctional Arousal in Depressed or Anxious Youth at Familial Risk for Bipolar Disorder. J. Pers. Med. 2022, 12, 1006. https://doi.org/10.3390/jpm12061006

AMA Style

Honeycutt DC, DelBello MP, Strawn JR, Ramsey LB, Patino LR, Hinman K, Welge J, Miklowitz DJ, Jo B, Blom TJ, et al. A Double-Blind Randomized Trial to Investigate Mechanisms of Antidepressant-Related Dysfunctional Arousal in Depressed or Anxious Youth at Familial Risk for Bipolar Disorder. Journal of Personalized Medicine. 2022; 12(6):1006. https://doi.org/10.3390/jpm12061006

Chicago/Turabian Style

Honeycutt, Duncan C., Melissa P. DelBello, Jeffrey R. Strawn, Laura B. Ramsey, Luis R. Patino, Kyle Hinman, Jeffrey Welge, David J. Miklowitz, Booil Jo, Thomas J. Blom, and et al. 2022. "A Double-Blind Randomized Trial to Investigate Mechanisms of Antidepressant-Related Dysfunctional Arousal in Depressed or Anxious Youth at Familial Risk for Bipolar Disorder" Journal of Personalized Medicine 12, no. 6: 1006. https://doi.org/10.3390/jpm12061006

APA Style

Honeycutt, D. C., DelBello, M. P., Strawn, J. R., Ramsey, L. B., Patino, L. R., Hinman, K., Welge, J., Miklowitz, D. J., Jo, B., Blom, T. J., Bruns, K. M., Hamill Skoch, S. K., Starace, N., Tallman, M. J., & Singh, M. K. (2022). A Double-Blind Randomized Trial to Investigate Mechanisms of Antidepressant-Related Dysfunctional Arousal in Depressed or Anxious Youth at Familial Risk for Bipolar Disorder. Journal of Personalized Medicine, 12(6), 1006. https://doi.org/10.3390/jpm12061006

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