Psychiatric safety of ketamine in psychopharmacology research

Edward B. Perry, Joyce A. Cramer, Hyun Sang Cho, Ismene L. Petrakis, Laurence P. Karper, Angelina Genovese, Elizabeth O'Donnell, John H. Krystal, D. Cyril D'Souza, A. Abi-Dargham, D. Abi-Saab, W. Abi-Saab, Y. W. Ammerman, A. Anand, A. Belger, A. Bennett, R. M. Berman, N. Boutros, M. B. Bowers, Alan Breier & 43 others J. D. Bremner, L. Brush, A. Cappiello, K. Cassello, D. S. Charney, H. Cho, N. L. Cooney, T. B. Cooper, J. Cramer, D. Damon, R. Delaney, D. C. D'Souza, G. K. Freeman, J. Gelernter, R. Gil, C. Grillon, R. Gueorguieva, G. R. Heninger, X. S. Hu, T. Hunsberger, P. Jatlow, L. P. Karper, J. H. Krystal, L. Levine, D. Limoncelli, D. S. Lipschitz, N. Liu, L. MacDougall, S. H. Madonick, K. Morrissey, S. Namenworth, D. A. Oren, E. B. Perry, I. L. Petrakis, J. P. Seibyl, P. Stetson, R. F. Suckow, L. A. Trevisan, S. Vegso, E. Webb, J. A. White, L. Zimmerman, E. Zuzarte

Research output: Contribution to journalArticle

80 Citations (Scopus)

Abstract

Rationale: A growing number of investigators are studying ketamine effects in healthy human subjects, but concerns remain about its safety as a research tool. Therefore, it is timely to revisit the safety of subanesthetic doses of ketamine in experimental psychopharmacology studies. Objective: To report on the safety of laboratory studies with subanesthetic doses of ketamine in healthy humans using an existing dataset. Materials and methods: Medically healthy subjects with no personal or familial Axis I psychotic spectrum disorders were administered subanesthetic doses of ketamine by intravenous infusion in a series of clinical investigations from 1989 to 2005. The safety of ketamine administration was monitored in these subjects. Results: Four hundred and fifty subjects received at least one dose of active ketamine. Eight hundred and thirty three active ketamine and 621 placebo infusions were administered. Ten adverse mental status events were documented in nine subjects/infusions that were deemed related to ketamine administration (2% of subjects, 1.45% of infusions). All but one adverse reaction resolved by the end of the test session. The side effects in the remaining individual were no longer clinically significant within 4 days of the test session. No residual sequelae were observed. Conclusion: Ketamine administration at subanesthetic doses appears to present an acceptable level of risk for carefully screened populations of healthy human subjects in the context of clinical research programs that intensively monitor subjects throughout their study participation.

Original languageEnglish (US)
Pages (from-to)253-260
Number of pages8
JournalPsychopharmacology
Volume192
Issue number2
DOIs
StatePublished - Jun 2007
Externally publishedYes

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Psychopharmacology
Ketamine
Psychiatry
Safety
Research
Healthy Volunteers
Intravenous Infusions
Psychotic Disorders
Placebos
Research Personnel

Keywords

  • Antagonist
  • NMDA receptor

ASJC Scopus subject areas

  • Pharmacology

Cite this

Perry, E. B., Cramer, J. A., Cho, H. S., Petrakis, I. L., Karper, L. P., Genovese, A., ... Zuzarte, E. (2007). Psychiatric safety of ketamine in psychopharmacology research. Psychopharmacology, 192(2), 253-260. https://doi.org/10.1007/s00213-007-0706-2

Psychiatric safety of ketamine in psychopharmacology research. / Perry, Edward B.; Cramer, Joyce A.; Cho, Hyun Sang; Petrakis, Ismene L.; Karper, Laurence P.; Genovese, Angelina; O'Donnell, Elizabeth; Krystal, John H.; D'Souza, D. Cyril; Abi-Dargham, A.; Abi-Saab, D.; Abi-Saab, W.; Ammerman, Y. W.; Anand, A.; Belger, A.; Bennett, A.; Berman, R. M.; Boutros, N.; Bowers, M. B.; Breier, Alan; Bremner, J. D.; Brush, L.; Cappiello, A.; Cassello, K.; Charney, D. S.; Cho, H.; Cooney, N. L.; Cooper, T. B.; Cramer, J.; Damon, D.; Delaney, R.; D'Souza, D. C.; Freeman, G. K.; Gelernter, J.; Gil, R.; Grillon, C.; Gueorguieva, R.; Heninger, G. R.; Hu, X. S.; Hunsberger, T.; Jatlow, P.; Karper, L. P.; Krystal, J. H.; Levine, L.; Limoncelli, D.; Lipschitz, D. S.; Liu, N.; MacDougall, L.; Madonick, S. H.; Morrissey, K.; Namenworth, S.; Oren, D. A.; Perry, E. B.; Petrakis, I. L.; Seibyl, J. P.; Stetson, P.; Suckow, R. F.; Trevisan, L. A.; Vegso, S.; Webb, E.; White, J. A.; Zimmerman, L.; Zuzarte, E.

In: Psychopharmacology, Vol. 192, No. 2, 06.2007, p. 253-260.

Research output: Contribution to journalArticle

Perry, EB, Cramer, JA, Cho, HS, Petrakis, IL, Karper, LP, Genovese, A, O'Donnell, E, Krystal, JH, D'Souza, DC, Abi-Dargham, A, Abi-Saab, D, Abi-Saab, W, Ammerman, YW, Anand, A, Belger, A, Bennett, A, Berman, RM, Boutros, N, Bowers, MB, Breier, A, Bremner, JD, Brush, L, Cappiello, A, Cassello, K, Charney, DS, Cho, H, Cooney, NL, Cooper, TB, Cramer, J, Damon, D, Delaney, R, D'Souza, DC, Freeman, GK, Gelernter, J, Gil, R, Grillon, C, Gueorguieva, R, Heninger, GR, Hu, XS, Hunsberger, T, Jatlow, P, Karper, LP, Krystal, JH, Levine, L, Limoncelli, D, Lipschitz, DS, Liu, N, MacDougall, L, Madonick, SH, Morrissey, K, Namenworth, S, Oren, DA, Perry, EB, Petrakis, IL, Seibyl, JP, Stetson, P, Suckow, RF, Trevisan, LA, Vegso, S, Webb, E, White, JA, Zimmerman, L & Zuzarte, E 2007, 'Psychiatric safety of ketamine in psychopharmacology research', Psychopharmacology, vol. 192, no. 2, pp. 253-260. https://doi.org/10.1007/s00213-007-0706-2
Perry EB, Cramer JA, Cho HS, Petrakis IL, Karper LP, Genovese A et al. Psychiatric safety of ketamine in psychopharmacology research. Psychopharmacology. 2007 Jun;192(2):253-260. https://doi.org/10.1007/s00213-007-0706-2
Perry, Edward B. ; Cramer, Joyce A. ; Cho, Hyun Sang ; Petrakis, Ismene L. ; Karper, Laurence P. ; Genovese, Angelina ; O'Donnell, Elizabeth ; Krystal, John H. ; D'Souza, D. Cyril ; Abi-Dargham, A. ; Abi-Saab, D. ; Abi-Saab, W. ; Ammerman, Y. W. ; Anand, A. ; Belger, A. ; Bennett, A. ; Berman, R. M. ; Boutros, N. ; Bowers, M. B. ; Breier, Alan ; Bremner, J. D. ; Brush, L. ; Cappiello, A. ; Cassello, K. ; Charney, D. S. ; Cho, H. ; Cooney, N. L. ; Cooper, T. B. ; Cramer, J. ; Damon, D. ; Delaney, R. ; D'Souza, D. C. ; Freeman, G. K. ; Gelernter, J. ; Gil, R. ; Grillon, C. ; Gueorguieva, R. ; Heninger, G. R. ; Hu, X. S. ; Hunsberger, T. ; Jatlow, P. ; Karper, L. P. ; Krystal, J. H. ; Levine, L. ; Limoncelli, D. ; Lipschitz, D. S. ; Liu, N. ; MacDougall, L. ; Madonick, S. H. ; Morrissey, K. ; Namenworth, S. ; Oren, D. A. ; Perry, E. B. ; Petrakis, I. L. ; Seibyl, J. P. ; Stetson, P. ; Suckow, R. F. ; Trevisan, L. A. ; Vegso, S. ; Webb, E. ; White, J. A. ; Zimmerman, L. ; Zuzarte, E. / Psychiatric safety of ketamine in psychopharmacology research. In: Psychopharmacology. 2007 ; Vol. 192, No. 2. pp. 253-260.
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abstract = "Rationale: A growing number of investigators are studying ketamine effects in healthy human subjects, but concerns remain about its safety as a research tool. Therefore, it is timely to revisit the safety of subanesthetic doses of ketamine in experimental psychopharmacology studies. Objective: To report on the safety of laboratory studies with subanesthetic doses of ketamine in healthy humans using an existing dataset. Materials and methods: Medically healthy subjects with no personal or familial Axis I psychotic spectrum disorders were administered subanesthetic doses of ketamine by intravenous infusion in a series of clinical investigations from 1989 to 2005. The safety of ketamine administration was monitored in these subjects. Results: Four hundred and fifty subjects received at least one dose of active ketamine. Eight hundred and thirty three active ketamine and 621 placebo infusions were administered. Ten adverse mental status events were documented in nine subjects/infusions that were deemed related to ketamine administration (2{\%} of subjects, 1.45{\%} of infusions). All but one adverse reaction resolved by the end of the test session. The side effects in the remaining individual were no longer clinically significant within 4 days of the test session. No residual sequelae were observed. Conclusion: Ketamine administration at subanesthetic doses appears to present an acceptable level of risk for carefully screened populations of healthy human subjects in the context of clinical research programs that intensively monitor subjects throughout their study participation.",
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T1 - Psychiatric safety of ketamine in psychopharmacology research

AU - Perry, Edward B.

AU - Cramer, Joyce A.

AU - Cho, Hyun Sang

AU - Petrakis, Ismene L.

AU - Karper, Laurence P.

AU - Genovese, Angelina

AU - O'Donnell, Elizabeth

AU - Krystal, John H.

AU - D'Souza, D. Cyril

AU - Abi-Dargham, A.

AU - Abi-Saab, D.

AU - Abi-Saab, W.

AU - Ammerman, Y. W.

AU - Anand, A.

AU - Belger, A.

AU - Bennett, A.

AU - Berman, R. M.

AU - Boutros, N.

AU - Bowers, M. B.

AU - Breier, Alan

AU - Bremner, J. D.

AU - Brush, L.

AU - Cappiello, A.

AU - Cassello, K.

AU - Charney, D. S.

AU - Cho, H.

AU - Cooney, N. L.

AU - Cooper, T. B.

AU - Cramer, J.

AU - Damon, D.

AU - Delaney, R.

AU - D'Souza, D. C.

AU - Freeman, G. K.

AU - Gelernter, J.

AU - Gil, R.

AU - Grillon, C.

AU - Gueorguieva, R.

AU - Heninger, G. R.

AU - Hu, X. S.

AU - Hunsberger, T.

AU - Jatlow, P.

AU - Karper, L. P.

AU - Krystal, J. H.

AU - Levine, L.

AU - Limoncelli, D.

AU - Lipschitz, D. S.

AU - Liu, N.

AU - MacDougall, L.

AU - Madonick, S. H.

AU - Morrissey, K.

AU - Namenworth, S.

AU - Oren, D. A.

AU - Perry, E. B.

AU - Petrakis, I. L.

AU - Seibyl, J. P.

AU - Stetson, P.

AU - Suckow, R. F.

AU - Trevisan, L. A.

AU - Vegso, S.

AU - Webb, E.

AU - White, J. A.

AU - Zimmerman, L.

AU - Zuzarte, E.

PY - 2007/6

Y1 - 2007/6

N2 - Rationale: A growing number of investigators are studying ketamine effects in healthy human subjects, but concerns remain about its safety as a research tool. Therefore, it is timely to revisit the safety of subanesthetic doses of ketamine in experimental psychopharmacology studies. Objective: To report on the safety of laboratory studies with subanesthetic doses of ketamine in healthy humans using an existing dataset. Materials and methods: Medically healthy subjects with no personal or familial Axis I psychotic spectrum disorders were administered subanesthetic doses of ketamine by intravenous infusion in a series of clinical investigations from 1989 to 2005. The safety of ketamine administration was monitored in these subjects. Results: Four hundred and fifty subjects received at least one dose of active ketamine. Eight hundred and thirty three active ketamine and 621 placebo infusions were administered. Ten adverse mental status events were documented in nine subjects/infusions that were deemed related to ketamine administration (2% of subjects, 1.45% of infusions). All but one adverse reaction resolved by the end of the test session. The side effects in the remaining individual were no longer clinically significant within 4 days of the test session. No residual sequelae were observed. Conclusion: Ketamine administration at subanesthetic doses appears to present an acceptable level of risk for carefully screened populations of healthy human subjects in the context of clinical research programs that intensively monitor subjects throughout their study participation.

AB - Rationale: A growing number of investigators are studying ketamine effects in healthy human subjects, but concerns remain about its safety as a research tool. Therefore, it is timely to revisit the safety of subanesthetic doses of ketamine in experimental psychopharmacology studies. Objective: To report on the safety of laboratory studies with subanesthetic doses of ketamine in healthy humans using an existing dataset. Materials and methods: Medically healthy subjects with no personal or familial Axis I psychotic spectrum disorders were administered subanesthetic doses of ketamine by intravenous infusion in a series of clinical investigations from 1989 to 2005. The safety of ketamine administration was monitored in these subjects. Results: Four hundred and fifty subjects received at least one dose of active ketamine. Eight hundred and thirty three active ketamine and 621 placebo infusions were administered. Ten adverse mental status events were documented in nine subjects/infusions that were deemed related to ketamine administration (2% of subjects, 1.45% of infusions). All but one adverse reaction resolved by the end of the test session. The side effects in the remaining individual were no longer clinically significant within 4 days of the test session. No residual sequelae were observed. Conclusion: Ketamine administration at subanesthetic doses appears to present an acceptable level of risk for carefully screened populations of healthy human subjects in the context of clinical research programs that intensively monitor subjects throughout their study participation.

KW - Antagonist

KW - NMDA receptor

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