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- || RL-007 / atai Life Sci
Trial completion date, Trial primary completion date: A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS) (clinicaltrials.gov) - Sep 19, 2024
P2, N=234, Recruiting, Sponsor: Recognify Life Sciences
Trial completion date: Nov 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jun 2025
- | Trial completion, Trial completion date, Trial primary completion date: A Study of Oral Ibogaine in Opioid Withdrawal (clinicaltrials.gov) - Aug 5, 2024
P1/2, N=116, Completed, Sponsor: atai Therapeutics, Inc.
Trial completion date: Nov 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jun 2025 Recruiting --> Completed | Trial completion date: Oct 2023 --> Jan 2024 | Trial primary completion date: Aug 2023 --> Jan 2024
- | Spravato (esketamine intranasal) / J&J
Journal: Single arketamine in treatment resistant depression: Presentation of 3 cases with regard to sick-leave duration. (Pubmed Central) - May 30, 2024
P, P2
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.
- ||||||| R-ketamine (PCN-101) / atai Life Sci, Otsuka
Trial completion, Trial primary completion date: Observation of Safety and Tolerability Within 1 Year of the Use of R-ketamine / Placebo in Drug-resistant Depression (clinicaltrials.gov) - May 28, 2024
P=N/A, N=3, Completed, Sponsor: Medical University of Gdansk
This study is registered in clinicaltrials.gov: NCT06232291. Enrolling by invitation --> Completed | Trial primary completion date: Oct 2023 --> May 2024
- RL-007 / atai Life Sci
RL-007, a Novel Oral Neuromodulator Being Developed to Treat Cognitive Impairment Associated with Schizophrenia (Modulo 1 - Affari) - Mar 16, 2024 - Abstract #SIRS2024SIRS_22;
RL-007 also acts synergistically with acetylcholine to enhance cholinergic signaling. RL-007 was found to be safe and well-tolerated, including in a CIAS population, and without typically observed GABAergic or cholinergic side effects.
- |||||| R-ketamine (PCN-101) / atai Life Sci, Otsuka
New trial: Observation of Safety and Tolerability Within 1 Year of the Use of R-ketamine / Placebo in Drug-resistant Depression (clinicaltrials.gov) - Jan 29, 2024
P=N/A, N=3, Enrolling by invitation, Sponsor: Medical University of Gdansk
- R-ketamine (PCN-101) / atai Life Sci, Otsuka
A RANDOMIZED, PLACEBO-CONTROLLED, EXPLORATORY, Double-Blind Study to Assess the Safety and Efficacy of Intravenous PCN-101 in Treatment-Resistant Depression (Salon 4) - May 9, 2023 - Abstract #ASCP2023ASCP_387;
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
- || Review, Journal: Novel antidepressant drugs: Beyond monoamine targets. (Pubmed Central) - Feb 27, 2023
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 treatment of MDD and TRD.
- ||||| RL-007 / atai Life Sci
New P2 trial: A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS) (clinicaltrials.gov) - Jan 17, 2023
P2, N=234, Recruiting, Sponsor: Recognify Life Sciences
- ||| R-ketamine (PCN-101) / atai Life Sci, Otsuka
Trial completion: A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD (clinicaltrials.gov) - Dec 20, 2022
P2, N=102, Completed, Sponsor: Perception Neuroscience
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 treatment of MDD and TRD. Active, not recruiting --> Completed
- ||| deuterated mitragynine (KUR-101) / atai Life Sci
Trial completion: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of KUR-101 in Healthy Adults (clinicaltrials.gov) - Dec 14, 2022
P1, N=60, Completed, Sponsor: Kures, Inc.
Active, not recruiting --> Completed Recruiting --> Completed
- || R-ketamine (PCN-101) / atai Life Sci, Otsuka
Enrollment closed: A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD (clinicaltrials.gov) - Nov 1, 2022
P2, N=102, Active, not recruiting, Sponsor: Perception Neuroscience
Recruiting --> Completed Recruiting --> Active, not recruiting
- |||| R-ketamine (PCN-101) / atai Life Sci, Otsuka
New P2 trial: A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD (clinicaltrials.gov) - Jun 9, 2022
P2, N=93, Recruiting, Sponsor: Perception Neuroscience
- || RL-007 / atai Life Sci
Biomarker, Trial completion: Safety, Biomarker Study of RL-007 in Subjects With Schizophrenia (clinicaltrials.gov) - Apr 27, 2022
P2, N=37, Completed, Sponsor: Recognify Life Sciences
Recruiting --> Active, not recruiting Recruiting --> Completed
- ||| deuterated mitragynine (KUR-101) / atai Life Sci
Enrollment open, Trial completion date: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of KUR-101 in Healthy Adults (clinicaltrials.gov) - Mar 15, 2022
P1, N=58, Recruiting, Sponsor: Kures, Inc.
Recruiting --> Completed Not yet recruiting --> Recruiting | Trial completion date: Jun 2022 --> Oct 2022
- | deuterated mitragynine (KUR-101) / atai Life Sci
New P1 trial: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of KUR-101 in Healthy Adults (clinicaltrials.gov) - Nov 8, 2021
P1, N=58, Not yet recruiting, Sponsor: Kures, Inc.
- || RL-007 / atai Life Sci
Biomarker, Enrollment open: Safety, Biomarker Study of RL-007 in Subjects With Schizophrenia (clinicaltrials.gov) - Sep 20, 2021
P2, N=32, Recruiting, Sponsor: Recognify Life Sciences
Not yet recruiting --> Recruiting | Trial completion date: Jun 2022 --> Oct 2022 Not yet recruiting --> Recruiting
- | ketamine / Generic mfg.
Preclinical, Journal: Rapid tolerance to behavioral effects of ethanol in rats: prevention by R-(-)-ketamine. (Pubmed Central) - Sep 16, 2021
(R)-ketamine (3 mg/kg) given prior to ETOH on Day 1 exhibited a strong trend toward preventing tolerance development (p=0.062). The present results extend prior findings on the potential value of (R)-ketamine in substance abuse disorder and add to the literature on NMDA receptor blockade as a tolerance-regulating mechanism.
- | New P1/2 trial: A Study of Oral Ibogaine in Opioid Withdrawal (clinicaltrials.gov) - Aug 30, 2021
P1/2, N=110, Recruiting, Sponsor: DemeRx IB, Inc.
- | RL-007 / atai Life Sci
Biomarker, New P2 trial: Safety, Biomarker Study of RL-007 in Subjects With Schizophrenia (clinicaltrials.gov) - Mar 29, 2021
P2, N=32, Not yet recruiting, Sponsor: Recognify Life Sciences