CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
D-serine +1 moredrug
Likely dose
D-serine 120 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03711500
NCT03711500Phase 2Completed

D-serine Augmentation of Neuroplasticity Based Auditory Learning in Schizophrenia

New York State Psychiatric Institute·interventional·Posted Oct 18, 2018·Updated Jun 14, 2022

In Brief

A Phase 2 clinical trial evaluating D-serine and Placebo for Schizophrenia and Schizo Affective Disorder. Completed, enrolled 45 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 18, 2018
Enrollment StartMar 13, 2019
Primary CompletionApr 30, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.7 years ago

Interventions

D-serinedrug

Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort

Placebodrug

Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort