Back to resultsD-serine and Cognitive Remediation in Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
D-serine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring cognitive remediation
Eligibility 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.
Sites / Locations
- Nathan Kline Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
D-serine
Arm Description
D-serine
Outcomes
Primary Outcome Measures
Mismatch Negativity (MMN)
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
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
Full Information
NCT ID
NCT02156908
First Posted
June 3, 2014
Last Updated
September 14, 2020
Sponsor
Nathan Kline Institute for Psychiatric Research
1. Study Identification
Unique Protocol Identification Number
NCT02156908
Brief Title
D-serine and Cognitive Remediation in Schizophrenia
Official Title
D-serine and Cognitive Remediation in Schizophrenia: Open Label Pilot
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nathan Kline Institute for Psychiatric Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
cognitive remediation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D-serine
Arm Type
Experimental
Arm Description
D-serine
Intervention Type
Drug
Intervention Name(s)
D-serine
Intervention Description
D-serine 60 mg/kg
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua T Kantrowitz, MD
Organizational Affiliation
Nathan Kline Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nathan Kline Institute
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27913408
Citation
Kantrowitz JT, Epstein ML, Beggel O, Rohrig S, Lehrfeld JM, Revheim N, Lehrfeld NP, Reep J, Parker E, Silipo G, Ahissar M, Javitt DC. Neurophysiological mechanisms of cortical plasticity impairments in schizophrenia and modulation by the NMDA receptor agonist D-serine. Brain. 2016 Dec;139(Pt 12):3281-3295. doi: 10.1093/brain/aww262.
Results Reference
result
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D-serine and Cognitive Remediation in Schizophrenia
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