Trial Outcomes & Findings for D-serine and Cognitive Remediation in Schizophrenia (NCT NCT02156908)
NCT ID: NCT02156908
Last Updated: 2020-10-08
Results Overview
An MMN event is evoked by a discernible change in the pitch of a repetitive auditory stimulation. The stronger the response to a difference (i.e., the more negative the amplitude of the MMN), the better the outcome. MMN was obtained to pitch deviant stimuli pre-post auditory plasticity training, utilizing deviants to the same base frequencies as the auditory plasticity sessions, (i.e. 500, 1000, and 2000 Hz), with \~10 minutes of each base frequency. MMN will be conducted at baseline and after the final session. Reported outcome is change in MMN between baseline and final within session.
COMPLETED
PHASE2
8 participants
3 weeks
2020-10-08
Participant Flow
Please see NCT01474395 for a related parallel study involving 13 schizophrenia patients and 13 healthy controls. Participants in NCT01474395 were not enrolled in the current study, i.e., both studies included separate groups of participants
Participant milestones
| Measure |
D-serine
D-serine
D-serine: D-serine 60 mg/kg (3 sessions, open label)
|
No Intervention
3 sessions without D-serine
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
D-serine and Cognitive Remediation in Schizophrenia
Baseline characteristics by cohort
| Measure |
D-serine
n=5 Participants
D-serine
D-serine: D-serine 60 mg/kg
|
No Intervention
n=3 Participants
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
45.4 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
44.0 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeksAn MMN event is evoked by a discernible change in the pitch of a repetitive auditory stimulation. The stronger the response to a difference (i.e., the more negative the amplitude of the MMN), the better the outcome. MMN was obtained to pitch deviant stimuli pre-post auditory plasticity training, utilizing deviants to the same base frequencies as the auditory plasticity sessions, (i.e. 500, 1000, and 2000 Hz), with \~10 minutes of each base frequency. MMN will be conducted at baseline and after the final session. Reported outcome is change in MMN between baseline and final within session.
Outcome measures
| Measure |
D-serine
n=5 Participants
D-serine
D-serine: D-serine 60 mg/kg
|
no Intervention
n=3 Participants
|
|---|---|---|
|
Mismatch Negativity (MMN)
|
.086 micro volts
Standard Deviation 0.36
|
0.31 micro volts
Standard Deviation .29
|
SECONDARY outcome
Timeframe: three weeksChange tone matching threshold (the percent difference in pitch of two consecutively played tones that can be distinguished), higher numbers represent better outcomes. D-serine outcomes are for 2 consecutive D-serine sessions
Outcome measures
| Measure |
D-serine
n=5 Participants
D-serine
D-serine: D-serine 60 mg/kg
|
no Intervention
n=3 Participants
|
|---|---|---|
|
Tone Matching Threshold
|
11 percentage of difference in pitch
Standard Deviation 3.6
|
2.3 percentage of difference in pitch
Standard Deviation 0.7
|
Adverse Events
D-serine
no Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place