drugset / Trial / NCT03711500
D-serine Augmentation of Neuroplasticity
Phase 1/2
Completed
45 enrolled
New York State Psychiatric Institute
Nathan Kline Institute for Psychiatric Research · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
Schizophrenia is a major public health problem associated with cognitive deficits, such as short and long term memory, executive functioning, attention and speed of processing that are amongst the strongest predictors of impaired functional outcome. In addition, schizophrenia patients show reduced "plasticity", defined as reduced learning. D-serine is a naturally occurring activator of the N-methyl-d-aspartate-type glutamate receptors (NMDAR) in the brain, and this project will assess the optimal dose of D-serine treatment over three sessions of a program designed to measure auditory plasticity.
Timeline
- Start
- 2019-03-13
- Primary completion
- 2021-04-30
- Completion
- 2021-04-30
Publications
- Govani V, Shastry AM, Iosifescu DV, Govil P, Mayer MR, Sobeih T, Choo TH, Wall MM, Sehatpour P, Kantrowitz JT. Augmentation of learning in schizophrenia by d-serine and auditory remediation is related to auditory and frontally-generated biomarkers: A randomized, double-blind, placebo-controlled study. Schizophr Res. 2023 Oct;260:205-208. doi: 10.1016/j.schres.2023.08.027. Epub 2023 Sep 11. No abstract available.
- Govani V, Shastry A, Iosifescu D, Govil P, Mayer M, Sobeih T, Choo T, Wall M, Sehatpour P, Kantrowitz J. Augmentation of learning in schizophrenia by D-serine is related to auditory and frontally-generated biomarkers: A randomized, double-blind, placebo-controlled study. Res Sq [Preprint]. 2023 May 19:rs.3.rs-2943290. doi: 10.21203/rs.3.rs-2943290/v1.
- Sehatpour P, Iosifescu DV, De Baun HM, Shope C, Mayer MR, Gangwisch J, Dias E, Sobeih T, Choo TH, Wall MM, Medalia A, Saperstein AM, Kegeles LS, Girgis RR, Carlson M, Kantrowitz JT. Dose-Dependent Augmentation of Neuroplasticity-Based Auditory Learning in Schizophrenia: A Double-Blind, Placebo-Controlled, Randomized, Target Engagement Clinical Trial of the NMDA Glutamate Receptor Agonist d-serine. Biol Psychiatry. 2023 Jul 15;94(2):164-173. doi: 10.1016/j.biopsych.2023.01.015. Epub 2023 Jan 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | D-serine | Unknown | 80 mg/kg | — |
| Subject | D-serine | Unknown | 100 mg/kg | — |
| Subject | D-serine | Unknown | 120 mg/kg | — |