Novel Antidepressants in the Pipeline (Phase II and III): A Systematic Review of the US Clinical Trials Registry
Hitoshi Sakurai, Kengo Yonezawa, Hideaki Tani, Masaru Mimura, Michael Bauer, Hiroyuki Uchida
Pharmacopsychiatry January 19, 2022 DOI: 10.1055/a-1714-9097 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Systematic review Peer reviewed |
|---|---|
| Interventions | AXS-05 ansofaxine hydrochloride MIJ821 nitrous oxide psilocybin ayahuasca facial injection of botulinum toxin A prasterone casopitant |
| Topics | Anxiety Depression Psilocybin |
| Keywords | Placebo Antidepressant Clinical trial Depression economics Pharmacology Hallucinogen Alternative medicine |
| Citations | 35 |
| Key findings | Nine antidepressant compounds with novel mechanisms of action demonstrated positive results over placebo in phase II or III trials for depression. |
Abstract
Abstract Introduction There is an imminent need for faster-acting and more effective antidepressants beyond the monoaminergic hypothesis.
Methods: We systematically searched the US Clinical Trials registry for antidepressant compounds with completed phase II and III trials. Compounds that demonstrated significant superiority over placebo in the primary outcome measure in the latest phase of phase II and III trials were identified. The collateral information was gathered via a PubMed search and press releases.
Results: Nine compounds were identified. AXS-05 (a combination of dextromethorphan and bupropion) and ansofaxine hydrochloride showed a positive result over placebo in a phase III study for major depressive disorder or treatment-resistant depression. MIJ821, nitrous oxide, psilocybin, ayahuasca, facial injection of botulinum toxin A, prasterone, and casopitant demonstrated at least one positive result in phase II trials. Ayahuasca showed a greater response rate than placebo at week one, indicating the rapid antidepressant effect.
Discussion: These new compounds with novel mechanisms of action are expected to provide a greater variety of treatment options for depression if preliminary positive results are confirmed.
Comparable studies
Other systematic reviews and meta-analyses on psilocybin for anxiety, most cited first.