Behavioral and Cognitive Effects of the N-methyl-D-aspartate Receptor (NMDAR) Co-agonist D-serine in Healthy Humans

NCT ID: NCT02051426

Last Updated: 2014-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2013-01-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: TRIPLE

Study Groups

D-serine

single P.O. administration of D-serine (2.1g)

Group Type: EXPERIMENTAL

D-serine

Intervention Type: OTHER

single P.O. administration of D-serine (2.1g)

Placebo

single P.O. administration of corn starch

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

single P.O. administration of Placebo

Interventions

D-serine

single P.O. administration of D-serine (2.1g)

Intervention Type: OTHER

Placebo

single P.O. administration of Placebo

Intervention Type: OTHER

Other Intervention Names

DSR; corn starch

Eligibility Criteria

Inclusion Criteria

• healthy volunteers

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Herzog Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uriel Heresco-Levy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Herzog Hospital

References

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.

Reference Type: DERIVED

PMID: 25554623 (View on PubMed)

Other Identifiers

112-06

Identifier Type: -

Identifier Source: org_study_id