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Outcome MeasureOther

CGI-S

Clinical Global Impression – Severity

5 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 3 studies with quantitative data.

Outcome data across 15 study arm–timepoint observations
SD
Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication
2023Secondary
25 mg COMP360(experimental)0194.31.0—
Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication
2023Secondary
25 mg COMP360(experimental)21192.91.8—
Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication
2023Secondary
25 mg COMP360(experimental)2119-1.3Δ1.3—
Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial
2025Secondary
Placebo(inactive)2——Δ——
Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial
2025Secondary
MM-120 25 µg(experimental)2——Δ——
Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial
2025Secondary
MM-120 50 µg(experimental)2——Δ——
Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial
2025Secondary
MM-120 100 µg(experimental)2——Δ——
Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial
2025Secondary
MM-120 200 µg(experimental)2——Δ——
Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial
2025Secondary
Placebo(inactive)7——Δ——
Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial
2025Secondary
MM-120 25 µg(experimental)7——Δ——

Papers Using CGI-S

Paywallindividual

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

In a 12‑week, open‑label phase 2a trial of a single 10 mg intranasal dose of 5‑methoxy‑N,N‑dimethyltryptamine (BPL‑003) in 12 patients with treatment‑resistant major depressive disorder, 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 across Days 2–85, 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., DJ, F., AH, Y.
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.
Paywallindividual

Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial

In a multicentre phase 2b randomised placebo‑controlled trial of 198 adults with moderate to severe GAD, a single dose of MM120 (lysergide D‑tartrate) produced a dose‑dependent reduction in HAM‑A scores at 4 weeks, with 100 µg and 200 µg showing significant improvements versus placebo (least‑squares mean differences −5.0 and −6.0 points, respectively). Adverse events were dose‑related—most commonly visual perceptual changes and nausea—supporting the efficacy and informing dose selection for phase 3 trials.

Published
Journal
JAMA
Authors
Robison, R., Barrow, R., Conant, C., Foster, E., Freedman, J. M., Jacobsen, P. L., Karas, S. M., Karlin, D. R., Solomon, T. M., Wernli, M. H., Fava, M. F., Jemisen, J.
Open Accessindividual

Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication

This open-label Phase II trial (n=19) investigates the safety, tolerability, and efficacy of synthetic psilocybin (COMP360) as an adjunct to selective serotonin reuptake inhibitors (SSRIs) in adults with treatment-resistant depression (TRD). The study found no serious treatment-emergent adverse events or increased suicidal ideation. It reported a significant decrease in depression (MADRS) and Clinical Global Impression-Severity (CGI-S) scores at week 3, with response and remission observed in 42.1% of participants.

Published
Journal
Neuropharmacology
Authors
Goodwin, G. M., Croal, M., Feifel, D., Kelly, J. R., Marwood, L., Mistry, S., O'keane, V., Peck, S. K., Simmons, H., Sisa, C., Stansfield, S. C., Tsai, J., Williams, S., Malievskaia, E.

Quick Facts

Full Name
Clinical Global Impression – Severity
Domain
Other
Papers Indexed
5
Score Range
1–7
Interpretation
Lower = better
Unit
points
Reference
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