Assessing measures of suicidal ideation in clinical trials with a rapid-acting antidepressant
Open accessAbstract
Rapid reduction of suicidal thoughts is critical for treating suicidal patients. Clinical trials evaluating these treatments require appropriate measurement. Key methodological issues include: 1) the use of single or multi-item assessments, and 2) evaluating whether suicidal ideation measures can track rapid change over time. The current study presents data from two randomized, placebo-controlled, crossover clinical trials evaluating ketamine in individuals with treatment-resistant depression (n = 60). Participants were assessed for suicidal thoughts using the Hamilton Depression Rating Scale (HAM-D), Montgomery-Asberg Depression Rating Scale (MADRS), Beck Depression Inventory (BDI), and Scale for Suicidal Ideation (SSI) at eight time points over three days. Assessments were compared using correlational analyses and effect sizes at 230 min and three days after ketamine infusion. Linear mixed models evaluated change in ideation across all time points. The HAM-D and MADRS suicide items demonstrated correlations of r > .80 with the first five items of the SSI (SSI5). On linear mixed models, an effect for ketamine was found for the HAM-D, MADRS, BDI items, and SSI5 (p < .001), but not for the full SSI (p = .88), which suggests a limited ability to assess change over time in patients with low levels of suicidal thoughts. Taken together, the results suggest that repeated suicidal assessments over minutes to days appear to detect improvement in suicidal thoughts after ketamine infusion compared to placebo. The MADRS suicide item, BDI suicide item, and SSI5 may be particularly sensitive to rapid changes in suicidal thoughts.
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A discrepancy was observed between the five-item SSI and the longer version over repeated assessments.
“While there was overall agreement between measures, a particular discrepancy was observed between the five-item SSI (screening items administered to every participant) and the longer version (five screening items plus 17 additional items only administered if the participant reached a particular score) over repeated assessments.”
From New methods for assessing rapid changes in suicide risk (2021) · cites this paper as [28]
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RetractedAn inventory for measuring depression
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Self-citationEvaluating Iatrogenic Risk of Youth Suicide Screening Programs: A Randomized Controlled Trial
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Self-citationIs it valid to measure suicidal ideation by depression rating scales?
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Self-citationWhat’s the Harm in Asking About Suicidal Ideation?
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Impact of screening for risk of suicide: randomised controlled trial
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Goldston, D. B., Nottelmann, E. D., Asharali, A., Daniel, S. S., Frazier, P. A., HARRIS, A. E., Longino, L., Manno, J. E., Reboussin, B. A., & Lewinsohn, P. M. (2000) · Cited by 89 · see citing works
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“total SSI in clinical trials of treatments such as ketamine may be able to capture rapid changes in symptoms over minutes to hours (Ballard et al., 2015).”
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“In one review of several ketamine clinical trials, Ballard and colleagues evaluated the MADRS, Beck Depression Inventory (BDI) (27), and HAM-D suicide items as well as the short (five-item) and long version of the SSI in the same participants (28).”
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“In terms of convergent validity, the BDI and HAMD suicidality items have been shown to be highly correlated (r¼ .80) with the first five items of the Beck Scale for Suicide Ideation (Ballard et al., 2015; see also Beck et al., 1997).”
KETAMINE: A POTENTIAL RAPID-ACTING ANTISUICIDAL AGENT?
Wilkinson, S. T., & Sanacora, G. (2016) · Depression and Anxiety · doi:10.1002/da.22498 · Cited by 39 · see citing works
“Moreover, further analysis from the same datasets using a slightly broader definition of SI found ketamine to have significant effects on SI rating on all scales, with the exception of the total score of the SSI, but there were significant effects noted as measured by the abbreviated SSI5 scale.[35] Consistent with th…”
MethodPrevalence and correlates of current suicidal ideation in women with premenstrual dysphoric disorder
Wikman, A., Sacher, J., Bixo, M., Hirschberg, A. L., Kallner, H. K., Epperson, C. N., Comasco, E., & Poromaa, I. S. (2022) · BMC Women s Health · doi:10.1186/s12905-022-01612-5 · Cited by 37 · see citing works
“Although not gold-standard assessment of suicidal ideation, the suicide item on MADRS-S correlates strongly with the multi-item assessment scale, the Scale for Suicide Ideation [2], and is a commonly used screening instrument in Swedish health care settings.”
MethodTrajectories of suicidal ideation after first‐episode psychosis: a growth mixture modeling approach
Salagre, E., Grande, I., Jiménez, E., Mezquida, G., Cuesta, M. J., Llorente, C., Amoretti, S., Lobo, A., González-Pinto, A. M., Carballo, J. J., et al. (2021) · Acta Psychiatrica Scandinavica · doi:10.1111/acps.13279 · Cited by 35 · see citing works
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“MADRS item 10 has been found to be a reliable assessment of rapid decrease in SI with ketamine (Ballard et al., 2015).”
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Magnetoencephalographic correlates of suicidal ideation in major depression
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“Clinically, ketamine administration significantly reduced both SI and depression scores in our sample, in line with previous findings (28, 54, 55).”
ResultSelf-citationVieira, F., Correia‐Melo, F. S., Santos‐Lima, C., Souza‐Marques, B., Leal, G. C.-G., Jesus‐Nunes, A. P., Mello, R. P., Caliman‐Fontes, A. T., Bandeira, I. D., Marback, R. F., et al. (2020) · General Hospital Psychiatry · doi:10.1016/j.genhosppsych.2020.12.011 · Cited by 29 · see citing works
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Chen, X., Wang, M., Hu, Y., Zhan, Y., Zhou, Y., Zheng, W., Liu, W., Wang, C., Zhong, X., Li, H., et al. (2021) · European Archives of Psychiatry and Clinical Neuroscience · doi:10.1007/s00406-020-01221-z · Cited by 27 · see citing works
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Li, W., Wang, C., Lan, X., Fu, L., Zhang, F., Ye, Y., Liu, H., Zhou, Y., & Ning, Y. (2022) · Journal of Psychiatric Research · doi:10.1016/j.jpsychires.2022.07.001 · Cited by 23 · see citing works
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“21,22 The Young Mania Rating Scale (YMRS) was used to assess symptoms of the opposite polarity (manic symptoms).”
MethodKetamine for Treatment of Suicidal Ideation and Reduction of Risk for Suicidal Behavior
Mallick, F., & McCullumsmith, C. B. (2016) · Current Psychiatry Reports · doi:10.1007/s11920-016-0680-7 · Cited by 22 · see citing works
Ketamine and esketamine for crisis management in patients with depression: Why, whom, and how?
Lengvenytė, A., Strumila, R., Olié, É., & Courtet, P. (2022) · European Neuropsychopharmacology · doi:10.1016/j.euroneuro.2022.02.004 · Cited by 21 · see citing works
Li, W.-C., Wang, C.-Y., Lan, X.-F., Fu, L., Zhang, F., Ye, Y., Liu, H., Wu, K., Zhou, Y.-L., & Ning, Y. (2022) · Journal of Affective Disorders · doi:10.1016/j.jad.2022.08.122 · Cited by 20 · see citing works
Brown, L. A., Wakschal, E. S., Block, S. R., Boisseau, C. L., Mancebo, M. C., Eisen, J. L., & Rasmussen, S. A. (2018) · Journal of Affective Disorders · doi:10.1016/j.jad.2018.11.006 · Cited by 19 · see citing works
Li, W.-C., Wang, C.-Y., Lan, X.-F., Fu, L., Zhang, F., Ye, Y., Liu, H., Wu, K., Lao, G.-H., Chen, J., et al. (2022) · Frontiers in Neuroscience · doi:10.3389/fnins.2022.937145 · Cited by 18 · see citing works
“This threshold has been described as a clinically significant cutoff for SI in previous studies (Holi et al., 2005; Ballard et al., 2015; Grunebaum et al., 2018).”
ResultChen, M., Bai, Y., Hsu, J.-W., Huang, K., & Tsai, S. (2024) · European Archives of Psychiatry and Clinical Neuroscience · doi:10.1007/s00406-024-01780-5 · Cited by 18 · see citing works
“…suicidal symptoms were defined according to the MADRS item 10 (suicidal thought) scores of ≤ 2 (weary of life; only fleeting suicidal thoughts) and ≥ 4 (feels better off dead; suicidal thoughts common and considered as possible solution but no specific plans/intention), respectively [15, 16].”
MethodCarruthers, S. P., Lee, S. J., Sankaranarayanan, A., Sumner, P. J., Toh, W. L., Tan, E. J., Neill, E., Rheenen, T. E. V., Gurvich, C., & Rossell, S. L. (2021) · Archives of Suicide Research · doi:10.1080/13811118.2021.1944412 · Cited by 16 · see citing works
Kim, S. T., Seo, J. H., Park, C. I., Kim, H. W., Boo, Y. J., Kim, H., Jeon, S., Kang, J. I., & Kim, S. J. (2022) · Psychiatry and Clinical Neurosciences · doi:10.1111/pcn.13503 · Cited by 15 · see citing works
“multi-item measures on suicidality, and has been shown to be sensitive to rapid changes in suicidal thoughts.(36) The MADRS suicide item score (0–6) was used as a continuous variable in the present study.”
MethodZeng, Q.-B., Zou, D.-C., Huang, X., Shang, D., Huang, X., Yang, X.-H., Ning, Y.-P., Balbuena, L., Xiang, Y., & Zheng, W. (2024) · Journal of Affective Disorders · doi:10.1016/j.jad.2024.09.038 · Cited by 15 · see citing works
(Es)Ketamine for Suicidal Ideation and Behavior: Clinical Efficacy
Alario, A. A., & Niciu, M. J. (2022) · Chronic Stress · doi:10.1177/24705470221128017 · Cited by 16 · see citing works
Self-citationLopes, E. I. T. C., Cavalcanti-Ribeiro, P., Palhano-Fontes, F., Gonçalves, K. T. D. C., Nunes, E. A., Lima, N. B. D. M., dos Santos, N. C., de Brito, A. J. C., de Araújo, D. B., & Coelho, N. L. G. (2024) · Journal of Psychiatric Research · doi:10.1016/j.jpsychires.2024.06.020 · Cited by 11 · see citing works
Clinical trials for rapid changes in suicidal ideation: lessons from ketamine
Ballard, E. D., Fields, J., Farmer, C. A., & Zarate, C. A. (2021) · Suicide and Life-Threatening Behavior · doi:10.1111/sltb.12663 · Cited by 10 · see citing works
“When comparing statistical outcomes between ketamine and saline placebo, no significant differences were observed between ketamine and saline placebo using the full-length SSI, but statistical differences were found using single items from the various depression rating scales (Ballard et al., 2015).”
MethodSelf-citationChen, M., Su, T., Chen, L., Li, C., Wu, H.-J., Lin, W., Tsai, S., Bai, Y., Mao, W., Tu, P., et al. (2023) · Journal of Psychiatric Research · doi:10.1016/j.jpsychires.2023.03.010 · Cited by 9 · see citing works
Bartoli, F., Cavaleri, D., Callovini, T., Palpella, D., Piacenti, S., Crocamo, C., & Carrà, G. (2024) · Journal of Psychosomatic Research · doi:10.1016/j.jpsychores.2024.111990 · Cited by 8 · see citing works
Cuomo, A., Pardossi, S., Barillà, G., Carmellini, P., Firenzuoli, B., Tarantino, F., Tinturini, R., & Fagiolini, A. M. (2025) · Journal of Affective Disorders · doi:10.1016/j.jad.2025.01.059 · Cited by 9 · see citing works
Wang, K., DiChiacchio, T., Fang, W. L., Lander, L. R., Feinberg, J., Xie, C., Winstanley, E. L., & Piamjariyakul, U. (2021) · Journal of Affective Disorders · doi:10.1016/j.jad.2021.10.018 · Cited by 8 · see citing works
Lamontagne, S. J., Gilbert, J. R., Zabala, P. K., Waldman, L. R., Zarate, C. A., & Ballard, E. D. (2023) · Psychological Medicine · doi:10.1017/s0033291723003331 · Cited by 8 · see citing works
Self-citationLópez‐Castromán, J., Jaussent, I., Gorwood, P. A. P. M., & Courtet, P. (2019) · Progress in Neuro-Psychopharmacology and Biological Psychiatry · doi:10.1016/j.pnpbp.2019.109762 · Cited by 8 · see citing works
Are suicide risk scales sensitive to change? A scoping review
Riblet, N. B. V., Matsunaga, S., Shiner, B. R., Schnurr, P. P., & Watts, B. V. (2023) · Journal of Psychiatric Research · doi:10.1016/j.jpsychires.2023.03.007 · Cited by 8 · see citing works
Yin, Y., Qian, S., Chen, Y., Sun, Y., Li, Y., Yu, Y., Li, J., Wu, Z., Yu, X., Ge, R., et al. (2021) · Frontiers in Behavioral Neuroscience · doi:10.3389/fnbeh.2021.640258 · Cited by 7 · see citing works
Chen, M., Bai, Y., Wu, H.-J., Li, C., Lin, W., Tsai, S., Su, T., & Tu, P. (2023) · Journal of Affective Disorders · doi:10.1016/j.jad.2023.08.061 · Cited by 7 · see citing works
Beaudequin, D. A., Can, A., Jones, M., Yang, C., Scherman, J. K., Dutton, M., Schwenn, P., Gallay, C. C., Jensen, E., Hermens, D. F., et al. (2021) · Psychiatry Research · doi:10.1016/j.psychres.2021.114212 · Cited by 6 · see citing works
Kang, H., Kim, J., Lee, J., Kim, S., Shin, I., Hong, Y. J., Ahn, Y., Jeong, M. H., & Kim, J. (2021) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2021.739823 · Cited by 5 · see citing works
“Although the suicide-related items of the MADRS are sensitive to changes in SI (30), future studies using scales (e.”
MethodInfluentialInfusing Hope Into the Treatment of Suicidality: a Review of Ketamine’s Effects on Suicidality
Rengasamy, M. L., Hsiung, K. S., & Price, R. B. (2019) · Current Behavioral Neuroscience Reports · doi:10.1007/s40473-019-00184-3 · Cited by 5 · see citing works
Bai, Y., Chen, M., Hsu, J.-W., Huang, H.-H., Jeng, J., & Tsai, S. (2024) · The International Journal of Neuropsychopharmacology · doi:10.1093/ijnp/pyae043 · Cited by 4 · see citing works
“…the participants into 3 groups: 0 (enjoys life or takes it as it comes), 2 (weary of life; only fleeting suicidal thoughts) or 3, and ≥4 (feels better off dead; suicidal thoughts common and considered as possible solution but no specific plans or intention) (Montgomery, 1980; Ballard et al., 2015).”
BackgroundSuicidality in treatment resistant depression: perspective for ketamine use.
Jakuszkowiak‐Wojten, K., Gałuszko‐Węgielnik, M., Wilkowska, A., Słupski, J., Włodarczyk, A., Górska, N., Szarmach, J., Szałach, Ł. P., Wiglusz, M. S., Krysta, K., et al. (2019) · PubMed · Cited by 4 · see citing works
Dahlgren, C. L., Tverrli, E., & Stewart, L. H. (2025) · Journal of Eating Disorders · doi:10.1186/s40337-025-01313-y · Cited by 3 · see citing works
“The MADRS item 10 has been reported to be well-suited for ongoing assessment of suicide risk when using rapid antidepressants like ketamine [45].”
Kim, J., Kim, J., Kang, H., Choi, W., Lee, J., Kim, S., Shin, I., Ahn, Y., & Jeong, M. H. (2024) · Journal of Affective Disorders · doi:10.1016/j.jad.2024.02.008 · Cited by 3 · see citing works
Ballard, E., & Price, R. (2016) · Springer eBooks · doi:10.1007/978-3-319-42925-0_4 · Cited by 2 · see citing works
Self-citationKayser, R. R., Haney, M., & Simpson, H. B. (2021) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2021.626150 · Cited by 2 · see citing works
Schlegelmilch, M., Plint, A. C., Barrowman, N. J., Gray, C., & Bhatt, M. (2024) · BMJ Open · doi:10.1136/bmjopen-2024-085681 · Cited by 2 · see citing works
Barzkar, M., Alavi, K., Malakouti, K., Khajeh-Azad, M.-A., Barzkar, F., Jalali Nadoushan, A. H., & Lahiji, M. N. (2025) · BMC Research Notes · doi:10.1186/s13104-024-07029-7 · Cited by 1 · see citing works
Vieira, F., Caliman‐Fontes, A. T., Souza‐Marques, B., Faria-Guimarães, D., Lins-Silva, D. H., Santos‐Lima, C., Jesus‐Nunes, A. P., & Quarantini, L. C. (2025) · Psychiatry Research · doi:10.1016/j.psychres.2025.116443 · Cited by 1 · see citing works
Strous, J. F. M., Roelandt, G. H. J., van Dalfsen, J. H., Kamphuis, J., Marijnissen, R. M., & Schoevers, R. A. (2025) · International Journal of Methods in Psychiatric Research · doi:10.1002/mpr.70044 · Cited by 1 · see citing works
“In one ketamine study with 60 depressed subjects the mean BSSI‐baseline score was 5 (Ballard et al. 2015).”
Borentain, S., McCormick, C. D., Joshi, K., O’Hara, M., Zhang, Q., Mulhern-Haughey, S., Richards, S., Anjo, J., Zante, D., Kewley, R. M., et al. (2022) · Research Square · doi:10.21203/rs.3.rs-2138354/v1
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“Scales with single items evaluated for suicide predictive power BDI - item 9 None were identified Yes [99 -101] The suicide item predicted deaths by suicide and suicide attempts.”
InfluentialMoleón-Ruiz, Á., de Toledo, P. Á., Narbona-Antúnez, J., Torres-Pereira, J., Pérez-Aquino, I., García-Ferriol, M., de Resende, M. B. D., Gutiérrez-Rojas, L., & García, M. M.-B. (2025) · Clinical Neurophysiology · doi:10.1016/j.clinph.2025.2110941
Lamontagne, S. J., Gilbert, J. R., Lee, Y., Neely, L. I., Waldman, L. R., Zarate, C. A., & Ballard, E. D. (2025) · Psychiatric Research and Clinical Practice · doi:10.1176/appi.prcp.20250049
Self-citationLi, T., Wang, Y., Li, F., Chen, X., Lu, B., Wang, Y., Li, X., Wang, Z., Li, H., Liao, Y., et al. (2026) · Journal of Affective Disorders · doi:10.1016/j.jad.2026.121200
Vidhya Joth, N. (2024) · Cuestiones de Fisioterapia · doi:10.48047/en272v57
Wu, P.-C., Lin, W.-C., Su, T., Li, C., Hh, W., Tsai, S., Bai, Y., Tu, P., Mao, W., & Chen, M. (2026) · Pharmacopsychiatry · doi:10.1055/a-2807-8161
Prise en charge médicamenteuse des patients souffrant de douleur chronique réfractaire
Corriger, A. (2019) · theses.fr (ABES) · doi:10.70675/668e4777zf8d0z4bdcz9780z0f91fedfe2b6
Schlegelmilch, M., Plint, A. C., Barrowman, N. J., Gray, C., Crawford, T., Kutcher, S. A., & Bhatt, M. (2026) · BMC Psychiatry · doi:10.1186/s12888-026-08042-9
“The psychometric validity of individual items, particularly in acute care settings, is less well established [19].”
Lombardo, G., Priestley, K., Hazelgrove, K. M., Bind, R. H., Biaggi, A., Conroy, S., Preez, A. D., Nikkheslat, N., Osborne, S., Pawlby, S. J., et al. (2026) · Brain Behavior and Immunity · doi:10.1016/j.bbi.2026.106601 · Cited by 1 · see citing works
Lim, J., Kim, H., Yang, C., Moon, H., Kim, Y., Ahn, J., Jang, J., & Kim, S. J. (2026) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2026.1796129
A pilot randomized trial of ketamine for suicidal ideation in a pediatric emergency department
Onikashvili, Y., Burt, H., Meckler, G. D., Bone, J. N., Hind, T., Sih, K., Sassi, R., Stillwell, K., Black, T. R., & Doan, Q. H. (2026) · Canadian Journal of Emergency Medicine · doi:10.1007/s43678-026-01190-7
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Emerging pharmacological and neuromodulation interventions for suicidal ideation and behaviour.
Scala, M., Magrini, E., Leccisotti, I., Serretti, A., Gonda, X., Sankar, A., Calati, R., Kasper, S., Altamura, M., Colizzi, M., et al. (2026) · European Neuropsychopharmacology · doi:10.1016/j.euroneuro.2026.112888
Treatments for individuals with suicidal thoughts: Use, indications, and helpfulness
Ballard, E. D., Hafermann, H. F., Hurst, K. T., Farmer, C., Greenstein, D. K., Kvarta, M. D., May, A. M., & Zarate, C. A. (2026) · Journal of Affective Disorders Reports · doi:10.1016/j.jadr.2026.101165
Self-citationBorkowska, M., Witaszczyk, M., Sołtan, A., Wiktorzak, N., Lipska, J., Prządka, J., Kochan-Olszewska, D., Rudnicki, L., Pawlicki, J., Laskus, J., et al. (2026) · International Journal of Innovative Technologies in Social Science · doi:10.31435/ijitss.3(51).2026.6636
“(11,13,14) The main interpretative challenges affecting suicidal ideation outcomes within the first 24 hours in ketamine and esketamine studies are summarized in Table 2.”
InfluentialTMS-EEG correlate of suicidal ideation in individuals with depression: A multi-site synthesis
Stapper, N., Sun, Y., Poorganji, M., Dhami, P., Hadas, I., Bailey, N. W., Kaewpijit, P., Zomorrodi, R., Kohn, J. N., Fitzgerald, P. B., et al. (2026) · Brain stimulation · doi:10.1016/j.brs.2026.103206
Suicidality during intranasal (es)ketamine treatment: A retrospective cohort study
Ehrt‐Schäfer, Y., Schoretsanitis, G., Seifritz, E., Olbrich, S., & Ferrea, S. (2026) · Journal of Affective Disorders · doi:10.1016/j.jad.2026.122647
- Authors
- Ballard, E. D., Luckenbaugh, D. A., Richards, E. M., Walls, T. L., Brutsché, N. E., Ameli, R., Niciu, M. J., Vande Voort, J. L., & Zarate, C. A.
- Affiliations
- National Institutes of Health (US)
- Corresponding author
- Ballard, Elizabeth D.
- Venue
- Journal of Psychiatric Research
- Publisher
- Elsevier BV
- Published
- 2015-09
- Volume
- 68
- Pages
- 68-73
- ISSN
- 0022-3956 (ISSN-L)
- PMC
- PMC4522045
- OpenAlex
- W2154057248
- Semantic Scholar
- 9d1bc02349f95fb8008876da0e4357f998f34c7d
- Cited by
- 80
- References
- 25
- Citations by year
- 2026: 12 · 2025: 8 · 2024: 8 · 2023: 7 · 2022: 9 · 2021: 13 · 2020: 1 · 2019: 13 · 2018: 2 · 2017: 1 · 2016: 6
- FWCI
- 2.16
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Psychiatric Research (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Brain and Behavior Research Foundation
- Brain Research Foundation
- National Institute for Health and Care Research
- National Institutes of Health (Z99 MH999999)
- National Institute of Mental Health
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Social Sciences › Psychology › Clinical Psychology › Suicide and Self-Harm Studies
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Keywords
- suicidal ideation, ketamine, treatment-resistant depression, rapid-acting antidepressants, Hamilton Depression Rating Scale, Montgomery-Asberg Depression Rating Scale, Beck Depression Inventory, measurement sensitivity
- MeSH terms
- Adolescent, Adult, Aged, Antidepressive Agents, Bipolar Disorder, Clozapine, Major Depressive Disorder, Female, Humans, Ketamine, Male, Middle Aged, Psychiatric Status Rating Scales, Statistics as Topic, Time Factors, Randomized Controlled Trials as Topic, Cross-Over Studies, Young Adult, Suicidal Ideation
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