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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition Healthy
Interventions Other: D-serine
Other: Placebo
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title D-serine First, Then Placebo Placebo First, Then D-serine
Hide Arm/Group Description D-serine (2.1g), then Placebo (corn starch) corn starch, then D-serine (2.1g)
Period Title: First Intervention
Started 16 19
Completed 16 19
Not Completed 0 0
Period Title: Washout Period of 1 Month
Started 16 19
Completed 16 19
Not Completed 0 0
Period Title: Second Intervention
Started 16 19
Completed 16 19
Not Completed 0 0
Arm/Group Title D-serine First, Then Placebo Placebo First, Then D-serine Total
Hide Arm/Group Description D-serine (2.1g), then placebo (corn starch) corn starch, then D-serine (2.1g) Total of all reporting groups
Overall Number of Baseline Participants 16 19 35
Hide Baseline Analysis Population Description
16 participants received DSR then 1month later received placebo; whereas19 participants received placebo then 1 month later received DSR. The assessments were performed at baseline assessment day and 2 hours after the experimental treatment administration (test day1&2). Outcome analysis was D-serine versus Placebo effects for total 35 participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 19 participants 35 participants
26.58  (3.0) 26.58  (3.0) 26.58  (3.0)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 19 participants 35 participants
female 5 8 13
male 11 11 22
1.Primary Outcome
Title Change in Visual Analogue Scale (VAS) of Anxiety - From Baseline to 2 Hours
Hide Description 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] ).
Time Frame Baseline, 2 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-serine Placebo
Hide Arm/Group Description:
D-serine (2.1g)
corn starch
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.5  (0.2) 0.0  (0.2)
2.Primary Outcome
Title Change in Cognitive Function- CPT-IP D-prime Score - From Baseline to 2 Hours
Hide Description 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.
Time Frame Baseline, 2 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-serine Placebo
Hide Arm/Group Description:
D-serine (2.1g)
corn starch
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
.5  (.2) 0  (.2)
3.Primary Outcome
Title Change in Rey Auditory Verbal Learning Test RAVLT (Trial 7) - From Baseline to 2 Hours
Hide Description 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.
Time Frame Baseline, 2 hours post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-serine Placebo
Hide Arm/Group Description:
D-serine (2.1g)
corn starch
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
2  (.3) .3  (.3)
Time Frame at the end of test days 1 and 2
Adverse Event Reporting Description Udvalg for Kliniske Undersogelser (UKU) Side Effects Rating Scale
 
Arm/Group Title D-serine Placebo
Hide Arm/Group Description D-serine (2.1g) corn starch
All-Cause Mortality
D-serine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
D-serine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
D-serine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Uriel Heresco-Levy, M.D.
Organization: Herzog Hospital
Phone: +972-2-5316906
Responsible Party: Herzog Hospital
ClinicalTrials.gov Identifier: NCT02051426     History of Changes
Other Study ID Numbers: 112-06
First Submitted: January 27, 2014
First Posted: January 31, 2014
Results First Submitted: February 26, 2014
Results First Posted: November 19, 2014
Last Update Posted: November 19, 2014