Table 4.
Ongoing, terminated, or completed clinical trials without results posted until September 2022
| Mood disorder | Drug | Dose | Phase | Type of study | NCT number | Trial design | Adjunctive treatment or monotherapy | Depressive symptoms severity scale at baseline | Population | Drug effectiveness on depressive symptoms | Status | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N | Range age | |||||||||||
| MDD | REL-1017 | 25 mg | III | Multicenter randomized double-blind placebo-controlled trial | NCT04688164 | 2 arms REL-1017 Placebo |
Adjunctive treatment | NA | 400 | 18–65 | Reduction in depressive symptoms at day 28 in the MADRS (Primary outcome) |
No results posted |
| 25 mg | III | Multicenter randomized double-blind placebo-controlled trial | NCT04855747 | 2 arms REL-1017 Placebo |
Adjunctive treatment | NA | 400 | 18–65 | Reduction in depressive symptoms at day 28 in the MADRS (Primary outcome) |
Recruiting | ||
| 25 mg | III | Multicenter randomized double-blind placebo-controlled trial | NCT05081167 | 2 arms REL-1017 Placebo |
Monotherapy | NA | 400 | 18–65 | Reduction in depressive symptoms at day 28 in the MADRS (Primary outcome) |
No results posted | ||
| 25 mg | III | Open-label trial | NCT04855760 | Single arm | Adjunctive treatment | NA | 600 | 18–65 | Incidence of TEAEs (Primary outcome) | Recruiting | ||
| Psilocybin | 25 mg | II | Randomized double-blind support-of-concept trial | NCT03866174 | 2 arms Psilocybin Active placebo |
Monotherapy (PAP) | NA | 100 | 21–65 | Reduction in depressive symptoms at day 43 in the MADRS (Primary outcome) |
Not recruiting | |
| 0.215 mg/kg | II | Randomized double-blind placebo-controlled trial | NCT03715127 | 2 arms Psilocybin Placebo |
Monotherapy (PAP) | MADRS ≥ 10/≤40 | 55 | 18–60 | Reduction in depressive symptoms at day 32 in the MADRS and BDI (Primary outcome) |
No results posted | ||
| 0.1 mg/kg 0.3 mg/kg |
I | Randomized double-blind placebo-controlled crossover trial | NCT03554174 | 4 arms Placebo-psilocybin 0.1 Placebo-psilocybin 0.3 Psilocybin 0.1-placebo Psilocybin 0.3-placebo |
Monotherapy (PAP) | NA | 18 | 18–65 | Reduction in depressive symptoms at weeks 1 and 2 after each experimental session in the GRID-HDRS | Not recruiting | ||
| 25 mg | II | Randomized double-blind placebo-controlled trial | NCT03380442 | 3 arms Psilocybin Ketamine No treatment group |
Monotherapy (PAP) | HDRS ≥ 17 | 60 | 18–64 | Reduction in depressive symptoms at months 3 and 6 in the QIDS (Primary outcome) |
Unknown | ||
| 25 mg | II | Randomized double-blind placebo-controlled trial | NCT04620759 | 2 arms Psilocybin Placebo |
Monotherapy (PAP) | GRID-HDRS ≥ 18 | 90 | 21–65 | Reduction in depressive symptoms at month 1 in the GRID-HDRS (Primary outcome) |
Recruiting | ||
| 25 mg | II | Randomized double-blind placebo-controlled trial | NCT04630964 | 2 arms Psilocybin Active placebo |
Monotherapy (PAP) | MADRS > 22/≤30 | 35 | 20–65 | Reduction in depressive symptoms at day 8 in the MADRS (Primary outcome) |
Not recruiting | ||
| Pimavanserin | 34 mg | III | Open-label trial | NCT04000009 | Single arm | Monotherapy | NA | 235 | >18 | Number of participants with TEAEs (Primary outcome) |
Terminated for business reasons and not due to safety concerns | |
| Zuranolone | 30 mg | III | Randomized double-blind placebo-controlled trial | NCT03771664 | 2 arms Zuranolone Placebo |
Monotherapy | HDRS ≥ 20 | 87 | 18–64 | Improvement of sleep efficiency assessed by polysomnography on day 14 (Primary outcome) |
Terminated (internal company decisions) | |
| 30 mg | III | Randomized double-blind placebo-controlled trial | NCT04007367 | 2 arms Zuranolone Placebo |
Monotherapy | HDRS ≥ 20 | 52 | 18–65 | Time to relapse of depressive symptoms (Primary outcome) |
Terminated (internal company decisions) | ||
| PRAX-114 | 10 mg 20 mg 40 mg 60 mg |
II | Randomized double-blind placebo-controlled dose-ranging trial | NCT04969510 | 5 arms PRAX-114 10 PRAX-114 20 PRAX-114 40 PRAX-114 60 Placebo |
Monotherapy adjunctive treatment | HDRS-17 ≥ 23 | 110 | 18–65 | Reduction in depressive symptoms at day 15 in the HDRS-17 (Primary outcome) |
No results posted | |
| Seltorexant | NA | I | Randomized double-blind placebo-controlled trial | NCT04951609 | 2 arms Seltorexant Placebo |
Adjunctive treatment | NA | 52 | 12–17 | Reduction in depressive symptoms at week 6 in the MADRS | Recruiting | |
| NA | I | Multicenter randomized double-blind Placebo and positive controlled four-way crossover Trial |
NCT04451187 | 4 arms Seltorexant dose 1 Seltorexant dose 2 Placebo Zoplicone |
Adjunctive treatment | MADRS ≥ 18 | 63 | 21–80 | Driving performance as assessed in an on-road driving test (Primary outcome) |
Not recruiting | ||
| NA | III | Multicenter randomized double-blind placebo-controlled parallel-group trial | NCT04532749 | 2 arms Seltorexant Placebo |
Adjunctive treatment | HDRS-17 ≥ 20 | 212 | 18–74 | Reduction in depressive symptoms at day 43 in the MADRS (Primary outcome) |
Stopped as a result of the interim analysis -no results posted | ||
| NA | III | Multicenter randomized double-blind placebo-controlled parallel-group trial | NCT04533529 | 2 arms Seltorexant Placebo |
Adjunctive treatment | HDRS-17 ≥ 20 | 550 | 18–74 | Reduction in depressive symptoms at week 6 in the MADRS (Primary outcome) |
Recruiting | ||
| NA | III | Randomized double-blind parallel-group trial | NCT04513912 | 2 arms Seltorexant quetiapine (extended-release) |
Adjunctive treatment | HDRS-17 ≥ 20 | 720 | 18–74 | Treatment response at week 26 in the MADRS (Primary outcome) |
Recruiting | ||
| TRD | AXS-05 | 45/105 mg | II | Randomized double-blind active placebo-controlled Trial |
NCT04971291 | 2 arms AXS-05 Bupropion |
Monotherapy | NA | 312 | 18–65 | Reduction in depressive symptoms at week 6 in the MADRS (Primary outcome) |
Enrolling by invitation |
| Psilocybin | 5 mg 25 mg |
II | Randomized double-blind active placebo-controlled parallel-group trial | NCT04670081 | 3 arms Psilocybin 5 Psilocybin 25 Placebo |
Monotherapy (PAP) | NA | 144 | 25–65 | Treatment response at week 6 in the HDRS (Primary outcome) |
Recruiting | |
For some studies, some data is not available (i.e. drug’s dose and depressive symptoms severity scale at baseline).
BDI, Beck Depression Inventory total score; GRID-HDRS, Grid-Hamilton Depression Rating Scale total score; HDRS, Hamilton Depression Rating Scale total score; MADRS, Montgomery-Asberg Depression Rating Scale total score; MDD, major depressive disorder; NA, not available; NMDAR, n-methyl-d-aspartate receptor; PAP, psilocybin assisted psychotherapy; QIDS, Quick Inventory of Depressive Symptomatology total score; TEAE, treatment-emergent adverse event; TRD, treatment-resistant depression.