Tal Burt MD Bibliography
The bibliography is the list of Dr. Burt's drug development publications in peer reviewed journals (* denotes senior authorship). There are 40 journal articles and 7 chapters/books including 24 first-authored and 8 senior-authored publications. The list includes annotations of noteworthy aspects of the publications.
Burt, T., Young, G., Lee, W., Kusuhara, H., Langer, O., Rowland, M., & Sugiyama, Y. (2020). Phase 0/microdosing approaches: time for mainstream application in drug development? Nature Reviews Drug Discovery. doi:10.1038/s41573-020-0080-x; PMID: 32901140 https://rdcu.be/b61rf
Burt, T., Vuong, L.T., Baker, E., Young, G.C., McCartt, A.D., Bergstrom, Y. Sugiyama and R. Combes. Phase 0, including microdosing approaches: Applying the Three Rs and increasing the efficiency of human drug development. Altern Lab Anim (2018), 46:335-46; PMID: 30657329
Burt, T., Button, K. S., Thom, H. H. Z., Noveck, R. J., Munafò, M. R. The Burden of the 'False-Negatives' in Clinical Development: Analyses of Current and Alternative Scenarios and Corrective Measures. Clin Transl Sci (2017), 1–10; PMID: 28675646
The first comprehensive analysis of the impact of under-powered early-phase studies on the productivity of drug development. Suggested intervention targeting strategic allocation of resources and related study design features are discussed.
Burt, T., MacLeod, D.B., Lee, K., Santoro, A., DeMasi, D. K., Hawk, T., Feinglos, M., Rowland, M., Noveck, R. J. Intra-Target Microdosing (ITM) - A Novel Drug Development Approach: Proof of Concept, Safety, and Feasibility Study in Humans. Clin Transl Sci (2017), 1–20; PMID: 28689370
First human Intra-Target Microdosing (ITM) study demonstrating the feasibility of the approach in detecting pharmacodynamic and proof-of-mechanism effects in targets of interest by administering a microdose directly to the target. Also demonstrating the utility of control contralateral measurement in modeling extrapolation over the microdose vs. therapeutic-level range.
Burt, T., Noveck, R.J., MacLeod, D.B., Layton, A.T., Rowland, M. & Lappin, G. Intra-Target Microdosing (ITM): A Novel Drug Development Approach Aimed at Enabling Safer and Earlier Translation of Biological Insights into Human Testing. Clinical and Translational Science. 10, 1-14, (2017). PMID: 28419765
This is the ITM concept manuscript describing the range of applications and modeling support.
*Nandal, S. & Burt, T. Integrating Pharmacoproteomics into Early-Phase Clinical Development: State-of-the-Art, Challenges, and Recommendations. International journal of molecular sciences 18, (2017). PMID: 28218733
Burt, T., C. S. John, J. L. Ruckle and L. T. Vuong (2016). "Phase-0/microdosing studies using PET, AMS, and LC-MS/MS: A range of study methodologies and conduct considerations. Accelerating development of novel pharmaceuticals through safe testing in humans - A practical guide." Expert Opin Drug Deliv. Aug 26. [Epub ahead of print]. PMID: 27564533
This article is a practical guide into Phase-0 approaches. It emphasizes the importance of initiating planning in advance (1.5.-2 years prior to IND) in order to make full use of the potential of these approaches. It also includes the first economic analysis on the impact of microdosing on the patent life of back-up compounds.
Choi YJ, Beck SH, Kang WY, Yoo S, Kim SY, Lee JS, Burt T. and Kim TW. (2016). "Knowledge and Perception about Clinical Research Shapes Behavior: Face to Face Survey in Korean General Public." J Korean Med Sci 31(5): 674-681. PMID: 27134486
Burt T, Dhillon S. (2016). "Pharmacometabolomics in Early-Phase Clinical Development." Clin Transl Sci. Apr 29. PMID: 27127917
Burt T, Yoshida K, Lappin G, Vuong LT, John C, De Wildt S N, Sugiyama Y, Rowland M (2016). "Microdosing and Other Phase-0 Clinical Trials: Facilitating Translation in Drug Development." Clin Transl Sci. 9(2): 74-88. PMID: 26918865
This article is a review of the applications and methodologies available with Phase-0/Microdosing approaches.
*Gupta S, Gersing KR, Erkanli A, Burt T. (2015). Antidepressant Regulatory Warnings, Prescription Patterns, Suicidality and Other Aggressive Behaviors in Major Depressive Disorder and Anxiety Disorders. Psychiatr Q. Aug 25 PMID: 26303613
Fam J, Rush JR, Burt T, Chan ESY, Siddiqui FJ, Assam PN, Lai OF, Chan HN, Ng BY, Khoo DH. (2015). Thyroid Autoimmune Antibodies and Major Depressive Disorder in Women. Ann Acad Med Singapore 44(8), 284-9. PMID: 26477960
Burt T, Rouse D, Lee K, Wu H, Layton A, Hawk TC, Weitzel DH, Chin BB, Cohen-Wolkowiez M, Chow SC, Noveck RJ. (2015). Intra-Arterial Microdosing (IAM): A Novel Drug Development Approach, Proof-of-Concept PET Study in Rats. J Nucl Med. Aug 27. 56(11):1793-9. PMID: 26315828
This is the first ITM POC study in animals. Insulin was administered locally at microdose to generate therapeutic level exposures.
Burt, T., Sharma, P., Dhillon, S., Manchanda, M., Mittal, S., Trehan, N. Clinical Research Environment in India: Challenges and Proposed Solutions. (2014). J Clin Res Bioeth 5(6), 1-8. PMID: 25590017
Burt, T., Gupta YK, Mehta N, Swamy N, Sovani V, Speers MA. Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research. (2014). J Clin Res Bioeth 5(5): 195. PMID: 25558428.
*Lappin, G., Noveck, R. & Burt, T. (2013). Microdosing and drug development: past, present and future. Expert Opin Drug Metab Toxicol 9, 817-34. PMID: 23550938
This is a meta-analysis of 35 studies that included exposures to microdose and therapeutic-level doses. It demonstrates that nearly 80% of drugs administered orally at microdose will extrapolate linearly to therapeutic level exposures. It also demonstrates that if administered IV 100% of the drugs studies extrapolate linearly to therapeutic level exposures.
Burt, T., Dhillon, S., Sharma, P., Khan, D., Mv, D., Alam, S., Jain, S., Alapati, B., Mittal, S. & Singh, P. (2013). PARTAKE survey of public knowledge and perceptions of clinical research in India. PLoS One 8, e68666. PMID: 23874712
Burt, T. & Dhillon, S. (2013). Pharmacogenomics in early-phase clinical development. Pharmacogenomics 14, 1085-97. PMID: 23837482
Burt, T., Sharma, P. & Mittal, S. (2012). Research Question, Study Design and Continuous Research Education and Training Exercises (CREATE) Program. J Clin Prev Card 1, 35-43. PMID: 26855934
*Preskorn, S. H., Greenblatt, D. J., Flockhart, D., Luo, Y., Perloff, E. S., Harmatz, J. S., Baker, B., Klick-Davis, A., Desta, Z. & Burt, T. (2007). Comparison of duloxetine, escitalopram, and sertraline effects on cytochrome P450 2D6 function in healthy volunteers. J Clin Psychopharmacol 27, 28-34. PMID: 17224709
Kamijima, K., Burt, T., Cohen, G., Arano, I. & Hamasaki, T. (2006). A placebo-controlled, randomized withdrawal study of sertraline for major depressive disorder in Japan. Int Clin Psychopharmacol 21, 1-9. PMID: 16317311
This is the first publication of a randomized withdrawal design in major depression. The reason for the design was the wish to have patients stay as little as possible on placebo when symptomatic. Patients on placebo experiencing withdrawal (i.e., resurgence of depressive symptoms) were withdrawn from the study. They were then given standard treatment. The withdrawal event was the primary outcome.
Steiner, M., Allgulander, C., Ravindran, A., Kosar, H., Burt, T. & Austin, C. (2005). Gender differences in clinical presentation and response to sertraline treatment of generalized anxiety disorder. Hum Psychopharmacol 20, 3-13. PMID: 15551351
*Sir, A., D'Souza, R. F., Uguz, S., George, T., Vahip, S., Hopwood, M., Martin, A. J., Lam, W. & Burt, T. (2005). Randomized trial of sertraline versus venlafaxine XR in major depression: efficacy and discontinuation symptoms. J Clin Psychiatry 66, 1312-20. PMID: 16259546
*Sackeim, H. A., Roose, S. P. & Burt, T. (2005). Optimal length of antidepressant trials in late-life depression. J Clin Psychopharmacol 25, S34-7. PMID: 16027559
Kamijima, K., Kuboki, T., Kumano, H., Burt, T., Cohen, G., Arano, I. & Hamasaki, T. (2005). A placebo-controlled, randomized withdrawal study of sertraline for panic disorder in Japan. Int Clin Psychopharmacol 20, 265-73. PMID: 16096517
This is the first publication of a randomized withdrawal design in psychiatry. The reason for the design was the wish to have patients stay as little as possible on placebo when symptomatic. Patients on placebo experiencing withdrawal (i.e., resurgence of panic symptoms) were withdrawn from the study. They were then given standard treatment. The withdrawal event was the primary outcome.
*Dahl, A. A., Ravindran, A., Allgulander, C., Kutcher, S. P., Austin, C. & Burt, T. (2005). Sertraline in generalized anxiety disorder: efficacy in treating the psychic and somatic anxiety factors. Acta Psychiatr Scand 111, 429-35. PMID: 15877709
*Sheikh, J. I., Cassidy, E. L., Doraiswamy, P. M., Salomon, R. M., Hornig, M., Holland, P. J., Mandel, F. S., Clary, C. M. & Burt, T. (2004). Efficacy, safety, and tolerability of sertraline in patients with late-life depression and comorbid medical illness. J Am Geriatr Soc 52, 86-92. PMID: 14687320
Finkel, S. I., Mintzer, J. E., Dysken, M., Krishnan, K. R., Burt, T. & McRae, T. (2004). A randomized, placebo-controlled study of the efficacy and safety of sertraline in the treatment of the behavioral manifestations of Alzheimer's disease in outpatients treated with donepezil. Int J Geriatr Psychiatry 19, 9-18. PMID: 14716694
Devanand, D. P., Adorno, E., Cheng, J., Burt, T., Pelton, G. H., Roose, S. P. & Sackeim, H. A. (2004). Late onset dysthymic disorder and major depression differ from early onset dysthymic disorder and major depression in elderly outpatients. J Affect Disord 78, 259-67. PMID: 15013252
Doraiswamy, P. M., Krishnan, K. R., Oxman, T., Jenkyn, L. R., Coffey, D. J., Burt, T. & Clary, C. M. (2003). Does antidepressant therapy improve cognition in elderly depressed patients? J Gerontol A Biol Sci Med Sci 58, M1137-44. PMID: 14684712
Burt, T., Lisanby, S. H. & Sackeim, H. A. (2002). Neuropsychiatric applications of transcranial magnetic stimulation: a meta analysis. Int J Neuropsychopharmacol 5, 73-103. PMID: 12057034
Sackeim, H. A., Keilp, J. G., Rush, A. J., George, M. S., Marangell, L. B., Dormer, J. S., Burt, T., Lisanby, S. H., Husain, M., Cullum, C. M., Oliver, N. & Zboyan, H. (2001). The effects of vagus nerve stimulation on cognitive performance in patients with treatment-resistant depression. Neuropsychiatry Neuropsychol Behav Neurol 14, 53-62. PMID: 11234909
Rush, A. J., George, M. S., Sackeim, H. A., Marangell, L. B., Husain, M. M., Nahas, Z., Burt, T. & Johnson, C. R. (2001). Vagus nerve stimulation. Psychiatric Clinics of North America: Annual of Drug Therapy, 55-87.
Burt, T. & Lane, R. M. (2001). Forced titration as a confound in an SSRI comparator study of sertaline versus citalopram in the treatment of major depressive disorder. Biol Psychiatry 50, 66-8. PMID: 11478291
George, M. S., Sackeim, H. A., Rush, A. J., Marangell, L. B., Nahas, Z., Husain, M. M., Lisanby, S., Burt, T., Goldman, J. & Ballenger, J. C. (2000). Vagus nerve stimulation: a new tool for brain research and therapy. Biol Psychiatry 47, 287-95. PMID: 10686263
Burt, T., Prudic, J., Peyser, S., Clark, J. & Sackeim, H. A. (2000). Learning and memory in bipolar and unipolar major depression: effects of aging. Neuropsychiatry Neuropsychol Behav Neurol 13, 246-53. PMID: 11186160
Burt, T. (2000). Donepezil and related cholinesterase inhibitors as mood and behavioral controlling agents. Curr Psychiatry Rep 2, 473-8. PMID: 1112299
Nierenberg, A. A., Burt, T., Matthews, J. & Weiss, A. P. (1999). Mania associated with St. John's wort. Biol Psychiatry 46, 1707-8. PMID: 1062455
Burt, T., Sachs, G. S. & Demopulos, C. (1999). Donepezil in treatment-resistant bipolar disorder. Biol Psychiatry 45, 959-64. PMID: 10386177
Burt, T., Lisanby, S. H., Boylan, L. S., Sackeim, H. A. & Dorme, J. (1999). 3. Vagus Nerve Stimulation (VNS) in Depression. The Journal of ECT 15, 105.
Ishak, W. W. & Burt, T. (1998). Computer applications in psychiatry: Role in patient care, education, research and communication. Cyberpsychology and Behavior 1, 147-150
Chapters & Books
Burt, T. & Combes, R. D. (2018). The Use of Imaging, Biomonitoring and Microdosing in Human Volunteers to Improve Safety Assessments and Clinical Development. In; M. Balls, R.D. Combes & A. Worth (Eds.), The History of Alternative Test Methods in Toxicology, Elsevier/Academic Press, 229-240. ISBN: 978-0-12-813697-3. https://doi.org/10.1016/B978-0-12-813697-3.00026-3
Burt, T., Hughes, L., Kalali, A. & Doraiswamy, P. M. (2014). Chapter 14 - Dementia Clinical Research in India. In Global Clinical Trials for Alzheimer's Disease (Bairu, M. & Weiner, M. W., eds.), pp. 231-246. Academic Press, San Diego.
IsHak, W. W., Burt, T. & Sederer, L. I. (2002). Outcome Measurement in Psychiatry: a Critical Review, American Psychiatric Pub., Washington, DC
Burt, T. & IsHak, W. W. (2002). The Use of Technology in Outcome Measurement. In Outcome Measurement in Psychiatry: a critical review (IsHak, W. W., Burt, T. & Sederer, L. I., eds.), pp. 383-391. American Psychiatric Pub., Washington, DC.
Burt, T. & IsHak, W. W. (2002). Outcome Measurement in Mood Disorders. In Outcome measurement in Psychiatry: a critical review (IsHak, W. W., Burt, T. & Sederer, L. I., eds.), pp. 155-190. American Psychiatric Pub., Washington, DC.
Burt T. (Assistant to the authors), in Kaplan and Sadock's Synopsis of Psychiatry. Edited by Kaplan HI, Sadock BJ. Baltimore, Williams & Wilkins, 1997
Burt T. (1997). Substance Withdrawal. In On Call Psychiatry (Bernstein, C. A., ed.). W B Saunders Co. ISBN-13: 978-0721665269.