Outcome MeasureOther

CGI-S

Clinical Global Impression – Severity

24 Papers in Blossom

About This Instrument

The CGI-S (Clinical Global Impression – Severity) is a clinician-rated 7-point scale assessing global severity of mental illness, from 1 (normal, not at all ill) to 7 (extremely ill). Developed by the NIMH, it is one of the most widely used instruments in psychopharmacology trials due to its brevity and cross-diagnostic applicability. It is typically paired with the CGI-I (Improvement) subscale. Used as a secondary outcome in many psychedelic clinical trials across depression, PTSD, and anxiety indications.

Outcome Data Across Studies

Reported results for CGI-S across 15 studies with quantitative data.

Outcome data across 45 study arm–timepoint observations
SD
A Double-Blind, Randomized, Placebo-Controlled, Dose-Frequency Study of Intravenous Ketamine in Patients With Treatment-Resistant Depression
2016Secondary
Ketamine 2x/week(experimental)2918-2.0——
A Double-Blind, Randomized, Placebo-Controlled, Dose-Frequency Study of Intravenous Ketamine in Patients With Treatment-Resistant Depression
2016Secondary
Placebo 2x/week(inactive)29150.0——
A Double-Blind, Randomized, Placebo-Controlled, Dose-Frequency Study of Intravenous Ketamine in Patients With Treatment-Resistant Depression
2016Secondary
Ketamine 3x/week(experimental)2917-2.0——
A Double-Blind, Randomized, Placebo-Controlled, Dose-Frequency Study of Intravenous Ketamine in Patients With Treatment-Resistant Depression
2016Secondary
Placebo 3x/week(inactive)29160.0——
Intravenous Ketamine for Adolescents with Treatment-Resistant Depression: An Open-Label Study
2018Secondary
Ketamine(experimental)0135.21.1—
Intravenous Ketamine for Adolescents with Treatment-Resistant Depression: An Open-Label Study
2018Secondary
Ketamine(experimental)1133.21.7—
A randomized, double-blind, active placebo-controlled study of efficacy, safety, and durability of repeated vs single subanesthetic ketamine for treatment-resistant depression
2020Secondary
Single ketamine + midazolam(active_comparator)0295.1——
A randomized, double-blind, active placebo-controlled study of efficacy, safety, and durability of repeated vs single subanesthetic ketamine for treatment-resistant depression
2020Secondary
Single ketamine + midazolam(active_comparator)12292.6—0.060
A randomized, double-blind, active placebo-controlled study of efficacy, safety, and durability of repeated vs single subanesthetic ketamine for treatment-resistant depression
2020Secondary
Six ketamine infusions(experimental)0255.3——
A randomized, double-blind, active placebo-controlled study of efficacy, safety, and durability of repeated vs single subanesthetic ketamine for treatment-resistant depression
2020Secondary
Six ketamine infusions(experimental)12252.0—0.060

Papers Using CGI-S

Open Accessindividual

Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression: The EPISODE Randomized Clinical Trial

In this triple‑blind, active placebo‑controlled randomised trial (n=144) of adults with treatment‑resistant depression, two 25 mg doses of psilocybin plus adjunct psychotherapy produced clinically meaningful reductions in depressive symptoms on exploratory secondary measures but did not significantly improve the pre‑second‑dose HAMD17 response rate versus nicotinamide.

Published
Journal
JAMA Psychiatry
Authors
Mertens, L. J., Koslowski, M., Betzler, F., Brand, M., Evens, R., Kärtner, L., Jungaberle, A., Jungaberle, H., Majić, T., Schmitz, C. N., Ströhle, A., Scharf, D., Spangemacher, M., Wolff, M., Assadi, Z., Bahri, S., Becher, L., Färber, L. V., Kirchen, N., Kulakova, E., Kunz, L., Meijer, A., Rohrmoser, B., Wellek, S., Berger, M. M., Gründer, G.
Paywallindividual

A phase 2 uncontrolled, open-label study of intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine) in patients with treatment-resistant depression

This 12‑week, open‑label Phase IIa trial of a single 10 mg intranasal dose of 5‑MeO-DMT (BPL‑003) in patients (n=12) with treatment‑resistant major depressive disorder, found that the drug was generally well tolerated with mostly mild–moderate adverse events and rapid discharge readiness (median ~98 minutes). A rapid and sustained mean MADRS reduction of 12–13 points was observed from Day 2 through Day 85, with most participants meeting response criteria and several achieving remission, supporting further evaluation in larger controlled trials.

Published
Journal
Journal of Psychopharmacology
Authors
Roberts, C., Seynaeve, M., Ermakova, A. O., Dunbar, F., Wells, H., Puri, A., Bird, C., Rucker, J. J.
Open Accessindividual

Long-term treatment with esketamine nasal spray in patients with treatment resistant depression: Results from the ESCAPE-LTE study

This Phase IV single-arm long-term extension trial (n=183) found that the vast majority of patients with treatment-resistant depression who achieved remission with esketamine nasal spray (plus an antidepressant) did not relapse over 136 weeks of treatment, with side effects largely resolving the same day and no new safety concerns identified.

Published
Journal
European Neuropsychopharmacology
Authors
Reif, A., Anıl, Y. A., Bitter, I., Buyze, J., Frey, R., Godinov, Y., Haggström, L., Kambarov, Y., Nielsen, R., Oliveira-Maia, A., von Holt, C., Cubała, W., Young, A. H., DJ, Fu.
Open Accessindividual

5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) for alcohol use disorder: An open-label, phase 2, proof-of-concept, clinical trial

In an open‑label Phase IIa trial (n-12), a single 10 mg intranasal dose of 5‑MeO‑DMT (BPL‑003) given alongside a 10‑week relapse‑prevention CBT programme was acceptable in safety and tolerability in people with moderate–severe alcohol use disorder. Over 12 weeks, participants showed large improvements in drinking (mean abstinent days rose from 33.2% to 80.8% and heavy drinking days fell from 56.2% to 13.2%), providing preliminary evidence of efficacy and supporting larger controlled trials.

Published
Journal
Addiction
Authors
Marsden, J., Kelleher, M., Dunbar, F., Ermakova, A. O., Mitcheson, L., Roberts, C., Rucker, J. J., Scott, G., Saeger, I., Small, F., Seynaeve, M.
Open Accessindividual

Safety and Efficacy of Repeated Low-Dose LSD for ADHD Treatment in Adults A Randomized Clinical Trial

In a 6‑week, multicentre, double‑blind randomised phase 2A trial of 53 adults with moderate–severe ADHD, twice‑weekly low‑dose LSD (20 μg) was physically safe and psychologically well tolerated. However, LSD did not reduce ADHD symptoms more than placebo on the AISRS.

Published
Journal
JAMA Psychiatry
Authors
Mueller, L., de Jesus, N. M. S., Schmid, Y., Müller, F., Becker, A. M., Klaiber, A., Straumann, I., Luethi, D., Haijen, E. C. H. M., Hurks, P. P. M., Kuypers, K. P. C., Liechti, M. E.
Open Accessindividual

Safety and Efficacy with Esketamine in Treatment-Resistant Depression: Long-Term Extension Study

In the phase 3 SUSTAIN-3 long-term extension (1,148 patients, 3,777 patient‑years), intermittent intranasal esketamine plus an oral antidepressant showed no new safety signals and an adverse event profile consistent with earlier studies. Depression severity improved during induction and was generally maintained during optimisation/maintenance, with remission in 35.6% at induction and about 48–50% at week 112/maintenance endpoint.

Published
Journal
International Journal of Neuropsychopharmacology
Authors
Zaki, N., Chen, N. )., Lane, R., Doherty, T., Drevets, W. C., Morrison, R. L., Sanacora, G., Wilkinson, S. T., Young, A. H., Chb, M. B., Lacerda, A. L. T., Paik, J. W., Popova, V., Fu, D. J.

Quick Facts

Full Name
Clinical Global Impression – Severity
Domain
Other
Papers Indexed
24
Score Range
1–7
Interpretation
Lower = better
Unit
points
Reference
Visit
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