Clinical trial NCT02051426: Behavioral and Cognitive Effects of the N-methyl-D-aspartate Receptor (NMDAR) Co-agonist D-serine in Healthy Humans
Official title: Behavioral and Cognitive Effects of the N-methyl-D-aspartate Receptor (NMDAR) Co-agonist D-serine in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: neuropsychiatric effects
Lead sponsor: Herzog Hospital
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The efficacy of compounds having agonistic activity at the glycine site associated with the N-methyl-D-aspartate receptor (NMDAR) is presently assessed in psychiatric disorders. In contrast to NMDAR antagonists, the neuropsychiatric effects of NMDAR agonists in the healthy human organism are not known. The investigators studied neuropsychiatric and neurochemical effects of the NMDAR-glycine site obligatory co-agonist D-serine (DSR) in healthy subjects using a randomized, controlled crossover challenge design including a baseline assessment day and two treatment administration days (DSR and placebo in randomized order). Thirty-five subjects aged 23-29 years participated in the study and received a 2.1g orally administered DSR dose. The main outcome measures were the changes in scores of mood-related Visual Analogue Scale (VAS), Continuous Performance Test - Identical Pairs (CPT-IP), and Rey Auditory Verbal Learning Test (RAVLT).

Detailed description: The study employed a randomized, double-blind, placebo controlled crossover design according to which, following a baseline assessment session, subjects were tested under two acute treatment conditions on two separate days. Following the baseline assessment day, 16 subjects were randomized, using a computer-generated random number sequence, to receive during test day 1 DSR and 19 to receive placebo. During test day 2, these two groups of subjects were crossed over to receive the alternative experimental treatment. The time intervals between the baseline assessment day, test day 1 and test day 2 were two to three weeks and 1 month respectively, in order to avoid the possibility of any carry-over effects.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* history of psychiatric, medical, neurological illness or substance abuse

Primary outcomes:
measure: Change in Visual Analogue Scale (VAS) of Anxiety - From Baseline to 2 Hours
timeFrame: Baseline, 2 hours post intervention
measure: Change in Cognitive Function- CPT-IP D-prime Score - From Baseline to 2 Hours
timeFrame: Baseline, 2 hours post intervention
measure: Change in Rey Auditory Verbal Learning Test RAVLT (Trial 7) - From Baseline to 2 Hours
timeFrame: Baseline, 2 hours post intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Herzog Hospital
name: Uriel Heresco-Levy, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levin R, Dor-Abarbanel AE, Edelman S, Durrant AR, Hashimoto K, Javitt DC, Heresco-Levy U. Behavioral and cognitive effects of the N-methyl-D-aspartate receptor co-agonist D-serine in healthy humans: initial findings. J Psychiatr Res. 2015 Feb;61:188-95. doi: 10.1016/j.jpsychires.2014.12.007. Epub 2014 Dec 24.