Effects of Psilocybin in Major Depressive Disorder
Summary
The proposed pilot study will assess whether people with major depressive disorder experience psychological and behavioral benefits and/or harms from psilocybin. This study will investigate acute and persisting effects of psilocybin on depressive symptoms and other moods, attitudes, and behaviors. The primary hypothesis is that psilocybin will lead to rapid and sustained antidepressant response, as measured with standard depression rating scales.
Timeline
- Start
- 2017-08-10
- Primary completion
- 2020-12-02
- Completion
- 2020-12-02
Outcome
Met primary endpoint
paper The mean (SD) GRID-HAMD scores at weeks 1 and 4 (8.0 [7.1] and 8.5 [5.7]) in the immediate treatment group were statistically significantly lower PMID 33146667 ↗
paper The effect sizes were large at week 5 (Cohen d = 2.5; 95% CI, 1.4-3.5; P < .001) and week 8 (Cohen d = 2.6; 95% CI, 1.5-3.7; P < .001). PMID 33146667 ↗
Publications
- Levin AW, Lancelotta R, Sepeda ND, Gukasyan N, Nayak S, Wagener TL, Barrett FS, Griffiths RR, Davis AK. The therapeutic alliance between study participants and intervention facilitators is associated with acute effects and clinical outcomes in a psilocybin-assisted therapy trial for major depressive disorder. PLoS One. 2024 Mar 14;19(3):e0300501. doi: 10.1371/journal.pone.0300501. eCollection 2024.
- Davis AK, Barrett FS, May DG, Cosimano MP, Sepeda ND, Johnson MW, Finan PH, Griffiths RR. Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 May 1;78(5):481-489. doi: 10.1001/jamapsychiatry.2020.3285.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Psilocybin | Other / unclassified | 20 mg/kg | Oral |
| Subject | Psilocybin | Other / unclassified | 30 mg/kg | Oral |