Outcome MeasureSafety / Adverse Events

C-SSRS

Columbia Suicide Severity Rating Scale

15 Papers in Blossom

About This Instrument

The Columbia Suicide Severity Rating Scale (C-SSRS) is a clinician-administered or self-report assessment tool developed by Kelly Posner and colleagues at Columbia University to evaluate suicidal ideation and behavior. It distinguishes between passive ideation (wish to be dead), active ideation (with or without plan/intent), preparatory behavior, and actual attempts, using a hierarchical severity scale. The C-SSRS is the FDA’s recommended instrument for assessing suicidality in all psychiatric clinical trials and has been adopted by the WHO, the Department of Defense, and the VA. In psychedelic research, the C-SSRS is administered at screening, baseline, and throughout treatment to monitor participant safety, as suicidality is an exclusion criterion in most trials and must be tracked as a potential adverse event. It is used in virtually every psilocybin, MDMA, and ketamine clinical trial. The C-SSRS is freely available and has been validated in over 100 countries and 140 languages.

Outcome Data Across Studies

Reported results for C-SSRS across 10 studies with quantitative data.

Outcome data across 26 study arm–timepoint observations
SD
Efficacy, Safety, and Durability of Repeated Ketamine Infusions for Comorbid Posttraumatic Stress Disorder and Treatment-Resistant Depression
2018Secondary
Six ketamine infusions(experimental)0331.61.4—
Efficacy, Safety, and Durability of Repeated Ketamine Infusions for Comorbid Posttraumatic Stress Disorder and Treatment-Resistant Depression
2018Secondary
Six ketamine infusions(experimental)0531.51.3—
Attenuation of antidepressant and antisuicidal effects of ketamine by opioid receptor antagonism
2019Secondary
Ketamine + Naltrexone/placebo(experimental)0125.10.5—
Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study
2020Safety
Group therapy + psilocybin(experimental)0180.51.0—
Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study
2020Safety
Group therapy + psilocybin(experimental)7180.30.8—
MDMA-assisted therapy significantly reduces eating disorder symptoms in a randomized placebo-controlled trial of adults with severe PTSD
2022Safety
MDMA-assisted therapy(experimental)0463.01.8—
MDMA-assisted therapy significantly reduces eating disorder symptoms in a randomized placebo-controlled trial of adults with severe PTSD
2022Safety
MDMA-assisted therapy(experimental)04612.55.4—
MDMA-assisted therapy significantly reduces eating disorder symptoms in a randomized placebo-controlled trial of adults with severe PTSD
2022Safety
Placebo with therapy(placebo)0433.01.5—
MDMA-assisted therapy significantly reduces eating disorder symptoms in a randomized placebo-controlled trial of adults with severe PTSD
2022Safety
Placebo with therapy(placebo)04312.35.9—
Efficacy and safety of a 4-week course of repeated subcutaneous ketamine injections for treatment-resistant depression (KADS study): randomised double-blind active-controlled trial
2023Secondary
Ketamine(experimental)0331.61.4—

Papers Using C-SSRS

Open Accessindividual

MDMA-assisted therapy as a treatment for major depressive disorder: proof of principle study

In an open‑label proof‑of‑principle study of 12 participants with moderate–severe major depressive disorder, two MDMA‑assisted therapy sessions plus psychotherapy were feasible, well tolerated and produced large, statistically significant reductions in depressive symptoms (mean MADRS change −19.3) and functional impairment. No unexpected or serious adverse events occurred, and the authors conclude that randomised trials are needed to confirm efficacy.

Published
Journal
British Journal of Psychiatry
Authors
Kvam, T. M., Goksøyr, I. W., Rog, J., Jentoft Van De Vooren, I. T., Stewart, H., Autran, I., Berthold-Losleben, M., Mørch-Johnsen, L., Holst, R., Clausen, I., Andreassen, O. A.
Open Accessindividual

An open-label, dose-escalation trial of psilocybin-assisted therapy for bipolar 2 depression

In an open-label, single-arm dose-escalation pilot (n=14) of psilocybin-assisted therapy for bipolar II depression, psilocybin (10 mg, with 25 mg if needed) was generally well tolerated and produced significant, sustained reductions in depressive symptoms and improved quality of life up to 90 days, with adverse events (including transient anxiety, nausea, headache and three notable psychiatric events) broadly comparable to other psilocybin studies. The authors conclude that randomised, placebo-controlled trials are needed to confirm efficacy and refine dosing protocols in this vulnerable population.

Published
Journal
OSF Preprints
Authors
Downey, A. E., Szigeti, B., Bradley, E. R., Fernandes-Osterhold, G., Sakai, K., Llerena, K., Nerayo, J., Fredenburg, L., Nielsen, B., Krystal, A. D., O'donovan, A., Gard, D. E., Woolley, J. D.
Paywallindividual

The Impact of Antidepressant Discontinuation Prior to Treatment with Psilocybin for Treatment-Resistant Depression

This post hoc analysis (n=233) of a Phase II RCT investigates the impact of recent antidepressant discontinuation (n=156) on the efficacy of psilocybin in treating treatment-resistant depression (TRD). The study compares outcomes between participants who discontinued antidepressants during screening and those who entered the trial free of these medications, finding no significant relationship between antidepressant discontinuation and worsening depression severity or compromised psilocybin treatment efficacy.

Published
Journal
Journal of Psychiatric Research
Authors
Marwood, L., Croal, M., Mistry, S., Simmons, H., Tsai, J., Young, M. B., Goodwin, G. M.
Open Accessindividual

Single-Dose Synthetic Psilocybin With Psychotherapy for Treatment-Resistant Bipolar Type II Major Depressive Episodes

In an open‑label, non‑randomised 12‑week trial of 15 patients with treatment‑resistant bipolar II depression, a single 25 mg dose of synthetic psilocybin plus psychotherapy produced large, rapid and sustained reductions in depressive symptoms (mean MADRS change −24 points at 3 weeks; 12/15 responders, 11/15 remissions) without significant increases in mania or suicidality. These preliminary results suggest psilocybin may be an effective and safe acute treatment for bipolar II depression and merit confirmation in larger randomised controlled trials.

Published
Journal
JAMA Psychiatry
Authors
Aaronson, S. T., van der Vaart, A., Miller, T., LaPratt, J., Swartz, K., Shoultz, A., Lauterbach, M., Sackeim, H. A., Suppes, T.
Paywallindividual

Effect of Repeated Intravenous Esketamine on Adolescents With Major Depressive Disorder and Suicidal Ideation: A Randomized Active-Placebo-Controlled Trial

This placebo-controlled trial (n=54) investigates the efficacy and safety of esketamine (iv, 17.5mg, 3x) in adolescents suffering from depression (MDD) and suicidal ideation (SI). It shows significant reductions in Columbia Suicide Severity Rating Scale (C-SSRS) Ideation and Intensity scores and Montgomery-Åsberg Depression Rating Scale (MADRS) scores in the esketamine group compared to the midazolam (placebo) group at day six, with maintained antisuicidal and antidepressant responses at four weeks post-treatment.

Published
Journal
Child and Adolescent Psychiatry
Authors
Zhou, Y., Lan, X-F., Wang, C., Zhang, F., Liu, H., Chao, Z., Ning, Y-P., Fu, L., Hu, Z., Li, W., Ye, Y.
Paywallindividual

MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial

This multi-site, randomised, double-blind, Phase IIIb trial (n=104) evaluated the efficacy and safety of MDMA-assisted therapy (MDMA-AT) for individuals with moderate to severe PTSD. The study found significant reductions in PTSD severity (CAPS-5 score) and functional impairment (SDS score) for the MDMA-AT group compared to placebo with therapy. Seven participants experienced severe treatment-emergent adverse events, but no deaths or serious adverse events were reported. The treatment was found to be generally well tolerated in a diverse population.

Published
Journal
Nature Medicine
Authors
Mitchell, J., Ot’alora G, M., van der Kolk, B., Shannon, S., Bogenschutz, M. P., Gelfand, Y., Paleos, C., Nicholas, C. R., Quevedo, S., Balliett, B., Hamilton, S., Mithoefer, A. T., Kleiman, S., Parker-Guilbert, K., Tzarfaty, K., Harrison, C., de Boer, A., Doblin, R., Yazar-Klosinski, B.

Quick Facts

Full Name
Columbia Suicide Severity Rating Scale
Domain
Safety / Adverse Events
Papers Indexed
15
Interpretation
Lower = better
Unit
ordinal
Reference
Visit
All Measures