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Clinical and Translational Science

ISSN 1752-8054

5 papers in the library · 120 citations · publishing 2016-2026

Papers

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Esketamine Nasal Spray: Mechanism of Action, Clinical, and Translational Science.

Clinical and Translational Science April 1, 2026 Matthijs W Van Hoogdalem, Dong-Jing Fu, Wayne C. Drevets et al.

Major depressive disorder (MDD) imposes a substantial burden worldwide, with treatment-resistant depression (TRD) and major depressive disorder with acute suicidal ideation or behavior (MDSI) representing two of the most severe clinical challenges. Conventional antidepressants often require several weeks to exert benefit, leaving patients symptomatic and at risk during this delay. Esketamine...

Safety, Pharmacokinetics, and Pharmacodynamics of a 6-h N,N-Dimethyltryptamine (DMT) Infusion in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled Trial.

Clinical and Translational Science May 1, 2025 Katelijne V. van der Heijden, Rob G J A Zuiker, Marije E. Otto et al. 7 citations

The serotonergic psychedelic N,N-dimethyltryptamine (DMT) presumably stimulates neuroplasticity in vitro and in vivo, by which it may exert neuroprotective effects during acute ischemic stroke. Since neuroplasticity has been implicated in the mechanism of action of rehabilitative therapy in stroke recovery, a pharmacological augmentation strategy facilitating neuroplasticity could be...

Population pharmacokinetic/pharmacodynamic modeling of the psychedelic experience induced by N,N‐dimethyltryptamine – Implications for dose considerations

Clinical and Translational Science September 11, 2022 Emma Eckernäs, Christopher Timmermann, Daniel Röshammar et al. 22 citations

Abstract N,N‐dimethyltryptamine (DMT) is a psychedelic compound that is believed to have potential as a therapeutic option in several psychiatric disorders. The number of clinical investigations with DMT is increasing. However, very little is known about the pharmacokinetic properties of DMT as well as any relationship between its exposure and effects. This study aimed to characterize...

A microdosing framework for absolute bioavailability assessment of poorly soluble drugs: A case study on cold‐labeled venetoclax, from chemistry to the clinic

Clinical and Translational Science January 8, 2022 Amr Alaarg, Rajeev Menon, David Rizzo et al.

Abstract This work presents an end‐to‐end approach for assessing the absolute bioavailability of highly hydrophobic, poorly water‐soluble compounds that exhibit high nonspecific binding using venetoclax as a model drug. The approach utilizes a stable labeled i.v. microdose and requires fewer resources compared with traditional approaches that use radioactive 14C‐labeled compounds. The stable...

Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development

Clinical and Translational Science February 26, 2016 Tal Burt, K Yoshida, Graham Lappin et al. 91 citations

Increasing costs of drug development and ethical concerns about the risks of exposing humans and animals to novel chemical entities favor limited exposure clinical trials such as microdosing and other phase 0 trials. An increasing body of research supports the validity of extrapolation from the limited drug exposure of phase 0 approaches to the full, therapeutic exposure. An increasing number...