D-serine AudRem: R33 Phase

Status Suspended

Clinical Trial 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 D-serine treatment over 16 weeks of a program designed to measure auditory plasticity.

Clinical Trial Description

D-Serine is a naturally occurring substance in the brain that activates the N-methyl-d-aspartate-type glutamate receptor (NMDAR). This receptor is thought to be important in both schizophrenia and plasticity (learning). My model proposes that problems with NMDAR within the brain leads to impaired plasticity, which in turn leads to impaired cognition. d-serine is an ideal NMDAR activator to study because it balances efficacy, availability and safety. Most d-serine studies have used a low dose, but the evidence for efficacy is even stronger for high dose d-serine, as will be tested in the current study. There has only been limited summary of higher dose d-serine, which is another important reason for this study. In addition to testing a potentially viable treatment in schizophrenia, a positive result would provide opportunities for use of D-serine in other populations (e.g. anxiety disorders or dementia) and stimulate the pharmaceutical industry to utilize this methodology to assess the efficacy of novel NMDAR modulators, using d-serine as a "gold-standard." The ultimate goal of this two part grant (R61-R33) study is to improve cognitive remediation by augmenting with D-serine. We recently completed the R61-phase, meeting our predetermined "milestones. " As predicted, D-serine led to significant enhancement of auditory plasticity and electrophysiological measures. During the three-year R33-phase, we will conduct a study of D-serine of 60 schizophrenia patients, assessing the effects of D-serine over 16 sessions of this program. Most successful, cognitive remediation programs are limited by lengthy (30-50 hours) treatments. Hypothesizing that adding D-serine will increase efficiency of cognitive remediation, successful completion of the R33-phase is defined as significant improvement in global cognition after 16 hours of treatment, and will serve as a pilot study to determine whether future, definitive clinical trials are warranted. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05046353
Study type	Interventional
Source	New York State Psychiatric Institute
Contact
Status	Suspended
Phase	Phase 1/Phase 2
Start date	December 1, 2022
Completion date	August 31, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05039489` - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia	N/A
Completed	`NCT05111548` - Brain Stimulation and Cognitive Training - Efficacy	N/A
Completed	`NCT05321602` - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder	Phase 1
Completed	`NCT04503954` - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia	N/A
Completed	`NCT02831231` - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium	Phase 1
Completed	`NCT05517460` - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center	N/A
Completed	`NCT03652974` - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy	Phase 4
Recruiting	`NCT04012684` - rTMS on Mismatch Negativity of Schizophrenia	N/A
Recruiting	`NCT04481217` - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia	N/A
Completed	`NCT00212784` - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)	Phase 3
Completed	`NCT04092686` - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia	Phase 3
Completed	`NCT01914393` - Pediatric Open-Label Extension Study	Phase 3
Recruiting	`NCT03790345` - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics	Phase 2/Phase 3
Recruiting	`NCT05956327` - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training	N/A
Terminated	`NCT03261817` - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders	N/A
Terminated	`NCT03209778` - Involuntary Memories Investigation in Schizophrenia	N/A
Completed	`NCT02905604` - Magnetic Stimulation of the Brain in Schizophrenia or Depression	N/A
Recruiting	`NCT05542212` - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia	N/A
Completed	`NCT04411979` - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia	N/A
Terminated	`NCT03220438` - TMS Enhancement of Visual Plasticity in Schizophrenia	N/A