Table 1.
Registered Phase 2 clinical trials using psychedelics with psychiatric patients*.
| Substance | Diagnosis | Number of trials (ongoing/complete) | Number of patients (planned/complete) | Masking | Controls | Effect size (min/max)° | Published references |
|---|---|---|---|---|---|---|---|
| Ketamine Route of administration (oral, intranasal, i.v.$) Dose Range (0.5–1.0 mg/kg oral, 0.2–0.5 mg/kg intranasal, 0.1–1.0 mg/kg i.v.) Number of drug sessions (1–12) | Depression# | 42/13 | 3,309/504 | Open label, single-blind, double blind | Placebo, lithium, saline, diphenhydramine, nitroprusside, midazolam, minocyclin, ECT | 0.99–1.67 | Fond et al., 2014; Coyle and Laws, 2015; Lee et al., 2015; McGirr et al., 2015; Parsaik et al., 2015; Romeo et al., 2015; Wan et al., 2015; Kishimoto et al., 2016; Xu et al., 2016 |
| OCD | 8/4 | 171/35 | Open label, double-blind | Placebo, saline, midazolam | 0.8 | Bloch et al., 2012; Rodriguez et al., 2013, 2016 | |
| PTSD | 5/1 | 318/41 | Double-blind | Placebo, midazolam | NA | Feder et al., 2014 | |
| Suicide+ | 5/1 | 718/12 | Open label, double-blind | Saline, midazolam | 0.67–0.84 | Ballard et al., 2014; Price et al., 2014; Murrough et al., 2015 | |
| Alcohol use disorder | 3/0 | 221/0 | Open label, double-blind | Placebo, midazolam | – | – | |
| Cocaine use disorder | 2/2 | 68/8 | Double-blind | Lorazepam | NA | Dakwar et al., 2014, 2016 | |
| Subtotal | 68/21 | 4,717/588*** | – | – | – | – | |
| MDMA Route of administration (oral) Dose Range (62.5–187.5 mg) Number of drug sessions (2–3) | PTSD | 12/6 | 152/108 | Open label, double-blind | Lactose, 25 mg MDMA, 30 mg MDMA | 1.17–1.24 | Bouso et al., 2008; Mithoefer et al., 2011, 2013, 2018; Oehen et al., 2013; Yazar-Klosinski and Mithoefer, 2017 |
| Social anxiety in autistic adults | 1/0 | 12/0§ | Double-blind | Inactive placebo | – | – | |
| Existential anxiety | 3/0 | 18/0 | Double-blind | Inactive placebo, 25 mg MDMA | – | – | |
| Alcohol use disorder | 1/0 | 20/0 | Open-label | Placebo | – | – | |
| Subtotal | 17/6 | 202/120 | – | – | – | – | |
| Psilocybin Route of administration (oral) Dose range (10–40 mg) Number of drug sessions (1–3) | Depression | 2/1 | 36/12 | Open label, double blind | Diphenhydramine | 2.0–3.1 | Carhart-Harris et al., 2016, 2017c |
| Existential anxiety | 2/2** | 80/80 | Double-blind | Placebo, 4 mg psilocybin | 0.82–1.63 | Grob et al., 2011; Griffiths et al., 2016; Ross et al., 2016 | |
| Alcohol dependence | 2/1$$ | 190/10 | Open-label, double blind | Diphenhydramine | 1.19–1.39 | Bogenschutz et al., 2015 | |
| Cocaine related disorders | 1/0 | 40/0 | Double-blind | Diphenhydramine | – | – | |
| Cigarette dependence | 1/1 | 15/15 | Open-label | Transdermal nicotine patch | NA | Johnson et al., 2014, 2017b; Garcia-Romeu et al., 2015 | |
| Subtotal | 8/5 | 361/117 | – | – | – | – | |
| LSD Route of administration (oral) Dose range (200 μm) Number of drug sessions (2) | Existential anxiety | 2/1 | 52/12 | Double-blind | Mannitol, 20 mg LSD | 1.1/1.2 | Gasser et al., 2014 |
| Total | – | 95/34 | 5,332/837 | – | – | – | – |
Data obtained from clinicaltrials.gov and clinicaltrialsregister.eu, last access July, 21, 2017.
Including registers for depression; major depression; depressive disorder; major depressive disorder; treatment resistant depression; bipolar depression; cancer depression; depression, suicide.
Including registers for Depression, suicide; MDD, suicide; BD, suicide; and suicidal ideas.
Status at clinical trials.gov as ongoing, but both have already been published (Griffiths et al., 2016; Ross et al., 2016).
Not registered as completed, but published (Bogenschutz et al., 2015).
There were 12 completed patients overlapping suicide and depression, 65 planned patients overlapping depression with alcohol use disorder and 16 planned patients overlapping depression with suicide. Each only counted once in the respective subtotals.
Generally infused over 40 min. °Reported as Standardized Mean Differences (Conhen's d), except psilocybin for depression, reported as Hedge's g. NA, Not Available at the published paper(s).