Trial Outcomes & Findings for Behavioral and Cognitive Effects of the N-methyl-D-aspartate Receptor (NMDAR) Co-agonist D-serine in Healthy Humans (NCT NCT02051426)

NCT ID: NCT02051426

Last Updated: 2014-11-19

Results Overview

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 \[maximum anxiety\] ).

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

Baseline, 2 hours post intervention

Results posted on

2014-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	D-serine First, Then Placebo D-serine (2.1g), then Placebo (corn starch)	Placebo First, Then D-serine corn starch, then D-serine (2.1g)
First Intervention STARTED	16	19
First Intervention COMPLETED	16	19
First Intervention NOT COMPLETED	0	0
Washout Period of 1 Month STARTED	16	19
Washout Period of 1 Month COMPLETED	16	19
Washout Period of 1 Month NOT COMPLETED	0	0
Second Intervention STARTED	16	19
Second Intervention COMPLETED	16	19
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	D-serine First, Then Placebo n=16 Participants D-serine (2.1g), then placebo (corn starch)	Placebo First, Then D-serine n=19 Participants corn starch, then D-serine (2.1g)	Total n=35 Participants Total of all reporting groups
Age, Continuous	26.58 years STANDARD_DEVIATION 3.0 • n=5 Participants	26.58 years STANDARD_DEVIATION 3.0 • n=7 Participants	26.58 years STANDARD_DEVIATION 3.0 • n=5 Participants
Sex/Gender, Customized female	5 participants n=5 Participants	8 participants n=7 Participants	13 participants n=5 Participants
Sex/Gender, Customized male	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 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 \[maximum anxiety\] ).

Outcome measures

Outcome measures
Measure	D-serine n=35 Participants D-serine (2.1g)	Placebo n=35 Participants corn starch
Change in Visual Analogue Scale (VAS) of Anxiety - From Baseline to 2 Hours	0.5 units on a scale Standard Deviation 0.2	0.0 units on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	D-serine n=35 Participants D-serine (2.1g)	Placebo n=35 Participants corn starch
Change in Cognitive Function- CPT-IP D-prime Score - From Baseline to 2 Hours	.5 units on a scale Standard Deviation .2	0 units on a scale Standard Deviation .2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	D-serine n=35 Participants D-serine (2.1g)	Placebo n=35 Participants corn starch
Change in Rey Auditory Verbal Learning Test RAVLT (Trial 7) - From Baseline to 2 Hours	2 units on a scale Standard Deviation .3	.3 units on a scale Standard Deviation .3

Adverse Events

D-serine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Uriel Heresco-Levy, M.D.

Herzog Hospital

Phone: +972-2-5316906

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place