R-ketamine (PCN-101) / atai Life Sci - LARVOL DELTA

Observation of Safety and Tolerability Within 1 Year of the Use of R-ketamine / Placebo in Drug-resistant Depression (clinicaltrials.gov) - P=N/A | N=3 | Completed | Sponsor: Medical University of Gdansk | Enrolling by invitation ➔ Completed | Trial primary completion date: Oct 2023 ➔ May 2024

Trial completion • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Single arketamine in treatment resistant depression: Presentation of 3 cases with regard to sick-leave duration. (PubMed, Asian J Psychiatr) - P, P2 | "Despite promising findings, the study faces limitations due to its small sample size, lack of randomization, and potential observational design biases. The results, while aligning with existing ketamine research, require cautious interpretation and warrant further investigation with larger, more robust studies. This exploration of R-KET's role in home-based TRD treatment opens avenues for future research, particularly focusing on its long-term effectiveness and safety in diverse patient populations. This study is registered in clinicaltrials.gov: NCT06232291."

Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Observation of Safety and Tolerability Within 1 Year of the Use of R-ketamine / Placebo in Drug-resistant Depression (clinicaltrials.gov) - P=N/A | N=3 | Enrolling by invitation | Sponsor: Medical University of Gdansk

New trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A RANDOMIZED, PLACEBO-CONTROLLED, EXPLORATORY, Double-Blind Study to Assess the Safety and Efficacy of Intravenous PCN-101 in Treatment-Resistant Depression (ASCP 2023) - "R-ketamine in a single dose demonstrated a trend towards efficacy at the 60 mg dose. Learning Objectives Understand efficacy of r-ketamine in TRD Understand safety of r-ketamine in TRD"

Clinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Mood Disorders • Psychiatry

A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD (clinicaltrials.gov) - P2 | N=102 | Completed | Sponsor: Perception Neuroscience | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Mood Disorders • Psychiatry

A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD (clinicaltrials.gov) - P2 | N=102 | Active, not recruiting | Sponsor: Perception Neuroscience | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Depression • Mood Disorders • Psychiatry

A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD (clinicaltrials.gov) - P2 | N=93 | Recruiting | Sponsor: Perception Neuroscience

New P2 trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

Novel antidepressant drugs: Beyond monoamine targets. (PubMed, CNS Spectr) - "The recent approval of intranasal Esketamine (glutamatergic agent) in conjunction with an oral antidepressant for the treatment of adult TRD patients was the first step toward expanding beyond the monoamine targets. Several other glutamatergic (AXS-05, REL-1017, AV-101, SLS-002, AGN24175, and PCN-101) and GABAergic (brexanolone, zuranolone, and ganaxolone) drugs are currently in different stages of clinical development for MDD, TRD and other indications. The renaissance of psychedelic drugs and the emergence of preliminary positive clinical trial results with psilocybin, Ayahuasca, 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), and lysergic acid diethylamide (LSD) may pave the way towards establishing this class of drugs as effective therapies for MDD, TRD and other neuropsychiatric disorders. Going beyond the monoamine targets appears to be an effective strategy to develop novel antidepressant drugs with superior efficacy, safety, and tolerability for the improved..."

Journal • Review • CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry

Perception Neuroscience initiates Phase 2a study of PCN-101 (R-ketamine) for treatment resistant depression (GlobeNewswire) - "Perception Neuroscience...today announced the initiation of a Phase 2a clinical study to evaluate the safety and efficacy of PCN-101 (R-ketamine)....The Phase 2a clinical trial has received the necessary regulatory and ethics approvals to initiate the study....Topline data from the study is expected to be reported at the end of 2022."

P2a data • Trial status • CNS Disorders • Depression

atai Life Sciences and Introspect Digital Therapeutics to test novel digital therapeutic approach in patients receiving ketamine for treatment resistant depression (GlobeNewswire) - "atai Life Sciences...announced a usability study of Introspect’s digital therapeutic (DTx) app technology in support of standard of care ketamine therapy for patients with treatment resistant depression (TRD) in collaboration with Kadima Neuropsychiatry. TRD impacts 100 million people globally, close to a third of the 300 million diagnosed with depression, many of whom are geographically restricted in their ability to access in-person psychological care."

eHealth • CNS Disorders • Depression

atai Life Sciences Reports Second Quarter 2021 Financial Results and Business Update (GlobeNewswire) - "PCN-101 is a parenteral formulation of R-ketamine, a glutamatergic modulator being developed as a rapid-acting antidepressant, with the potential to be an at-home non-dissociative alternative to S-ketamine...Phase 2 randomized, double blind, placebo-controlled trial in patients with treatment-resistant depression (TRD) to be initiated in the third quarter and expected to run through late 2022; The trial will assess efficacy and safety, dose response and duration of action in patients with TRD....COMP360 is a proprietary formulation of synthetic psilocybin...Phase 2b trial results are expected in late 2021."

New P2 trial • P2b data • CNS Disorders • Depression