D-serine and Cognitive Remediation in Schizophrenia

Sponsor
Nathan Kline Institute for Psychiatric Research (Other)
Overall Status
Completed
CT.gov ID
NCT02156908
Collaborator
(none)
8
1
1
16
0.5

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

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
D-serine and Cognitive Remediation in Schizophrenia: Open Label Pilot
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: D-serine

D-serine

Drug: D-serine
D-serine 60 mg/kg

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:
NCT02156908
Other Study ID Numbers:
  • 601945
First Posted:
Jun 5, 2014
Last Update Posted:
Oct 8, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Keywords provided by Nathan Kline Institute for Psychiatric Research
Additional relevant MeSH terms:

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

1. Primary Outcome
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)
2. Secondary Outcome
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

[Not Specified]

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
Email josh.kantrowitz@nki.rfmh.org
Responsible Party:
Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:
NCT02156908
Other Study ID Numbers:
  • 601945
First Posted:
Jun 5, 2014
Last Update Posted:
Oct 8, 2020
Last Verified:
Sep 1, 2020