D-serine and Cognitive Remediation in Schizophrenia
Study Details
Study Description
Brief Summary
The investigators will test the effects of 3 days of D-serine (DSR) on auditory plasticity in a sensory based remediation (SBR) paradigm
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
We will enroll 8 subjects in an open label, three session pilot in patients will receive three sessions of tone matching SBR.
5 Subjects will receive D-serine (60mg/kg) taken 1x each week during the SBR sessions. Subjects will receive study drug 30 minutes prior to session.
3 subjects received no intervention
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: D-serine D-serine |
Drug: D-serine
D-serine 60 mg/kg
|
Outcome Measures
Primary Outcome Measures
- Mismatch Negativity (MMN) [3 weeks]
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.
Secondary Outcome Measures
- Tone Matching Threshold [three weeks]
Change 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
Eligibility Criteria
Criteria
Inclusion criteria:
-
18 to 64 years old,
-
IQ≥85 and
-
estimated Glomerular Filtration Rate (GFR) ≥60. All oral and depot antipsychotics (with the exception of clozapine) are allowable. Patients must be on their antipsychotic medication for 1 month and stable on dose of antipsychotic and adjunctive medications for 2 weeks prior to study entry.
Exclusion criteria:
-
history of neurological visual or hearing impairment,
-
active suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS),
-
current alcohol or drug abuse (<1 month) or substance dependence (<4 months). All women of child-bearing potential must have a negative urine pregnancy test at the baseline visit. We require an IQ of ≥85 to ensure that subjects will have a capacity to learn. In our cross-sectional studies, we have observed an IQ≥85 in over 90% of candidates, suggesting that this is not an overly restrictive criterion.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Nathan Kline Institute | Orangeburg | New York | United States | 10962 |
Sponsors and Collaborators
- Nathan Kline Institute for Psychiatric Research
Investigators
- Principal Investigator: Joshua T Kantrowitz, MD, Nathan Kline Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 601945
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | 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 |
Arm/Group Title | D-serine | No Intervention |
---|---|---|
Arm/Group Description | D-serine D-serine: D-serine 60 mg/kg (3 sessions, open label) | 3 sessions without D-serine |
Period Title: Overall Study | ||
STARTED | 5 | 3 |
COMPLETED | 5 | 3 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | D-serine | No Intervention | Total |
---|---|---|---|
Arm/Group Description | D-serine D-serine: D-serine 60 mg/kg | Total of all reporting groups | |
Overall Participants | 5 | 3 | 8 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
43.2
(9.4)
|
45.4
(14.3)
|
44.0
(10.5)
|
Sex: Female, Male (Count of Participants) | |||
Female |
1
20%
|
0
0%
|
1
12.5%
|
Male |
4
80%
|
3
100%
|
7
87.5%
|
Outcome Measures
Title | Mismatch Negativity (MMN) |
---|---|
Description | 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. |
Time Frame | 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | D-serine | no Intervention |
---|---|---|
Arm/Group Description | D-serine D-serine: D-serine 60 mg/kg | |
Measure Participants | 5 | 3 |
Mean (Standard Deviation) [micro volts] |
.086
(0.36)
|
0.31
(.29)
|
Title | Tone Matching Threshold |
---|---|
Description | Change 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 |
Time Frame | three weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | D-serine | No Intervention |
---|---|---|
Arm/Group Description | D-serine D-serine: D-serine 60 mg/kg | |
Measure Participants | 5 | 3 |
Mean (Standard Deviation) [percentage of difference in pitch] |
11
(3.6)
|
2.3
(0.7)
|
Adverse Events
Time Frame | 3 weeks | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | D-serine | no Intervention | ||
Arm/Group Description | D-serine D-serine: D-serine 60 mg/kg | no intervention | ||
All Cause Mortality |
||||
D-serine | no Intervention | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/5 (0%) | 0/3 (0%) | ||
Serious Adverse Events |
||||
D-serine | no Intervention | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/5 (0%) | 0/3 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
D-serine | no Intervention | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/5 (0%) | 0/3 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Joshua Kantrowitz |
---|---|
Organization | Nathan Kline Institute |
Phone | 646-774-6738 |
josh.kantrowitz@nki.rfmh.org |
- 601945