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

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ClinicalTrials.gov Identifier: NCT02051426
Recruitment Status : Completed
First Posted : January 31, 2014
Results First Posted : November 19, 2014
Last Update Posted : November 19, 2014
Sponsor:
Information provided by (Responsible Party):
Herzog Hospital

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).

Condition or disease Intervention/treatment Phase
Healthy Other: D-serine Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Behavioral and Cognitive Effects of the N-methyl-D-aspartate Receptor (NMDAR) Co-agonist D-serine in Healthy Humans
Study Start Date : April 2007
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: D-serine
single P.O. administration of D-serine (2.1g)
Other: D-serine
single P.O. administration of D-serine (2.1g)
Other Name: DSR

Placebo Comparator: Placebo
single P.O. administration of corn starch
Other: Placebo
single P.O. administration of Placebo
Other Name: corn starch




Primary Outcome Measures :
  1. Change in Visual Analogue Scale (VAS) of Anxiety - From Baseline to 2 Hours [ Time Frame: Baseline, 2 hours post intervention ]
    The subject was asked to point on the VAS scale according to his anxiety level. VAS anxiety scale 0 to 10 ( 0 [no anxiety] to 10 [maximum anxiety] ).

  2. Change in Cognitive Function- CPT-IP D-prime Score - From Baseline to 2 Hours [ Time Frame: Baseline, 2 hours post intervention ]
    The "d-prime score" is a score given to each participant on a scale of 0.0 - 1.0 in which discrimination sensitivity is measured. A score of 0 equates to no sensitivity whereas a score of 1.0 equates to perfect sensitivity.

  3. Change in Rey Auditory Verbal Learning Test RAVLT (Trial 7) - From Baseline to 2 Hours [ Time Frame: Baseline, 2 hours post intervention ]
    RAVLT measures short term verbal memory, verbal learning, susceptibility to (proactive and retroactive) interference, retention of information after a certain period of time during which other activities are performed and recognition memory. The test consists of a list of 15 common nouns, which are read to the subject in five consecutive trials (trials 1 through 5); each reading is followed by a free-recall task. In trial 6, an interface list of 15 new common nouns is presented, followed by free recall of these new nouns. In trial 7, without additional reading, subjects are again asked to recall the first list. Twenty minutes later, without an additional reading, subjects are asked to recall once more the first list (trial 8). The RAVLT score range from 0-90 correctly recalled words. For trial 7 the score ranges from 0 to 15 correctly recalled words.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051426


Sponsors and Collaborators
Herzog Hospital
Investigators
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Principal Investigator: Uriel Heresco-Levy, M.D. Herzog Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Herzog Hospital
ClinicalTrials.gov Identifier: NCT02051426     History of Changes
Other Study ID Numbers: 112-06
First Posted: January 31, 2014    Key Record Dates
Results First Posted: November 19, 2014
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Herzog Hospital:
neuropsychiatric effects

Additional relevant MeSH terms:
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N-Methylaspartate
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs