D-serine and Cognitive Remediation in Schizophrenia

Overview

The investigators will test the effects of 3 days of D-serine (DSR) on auditory plasticity in a sensory based remediation (SBR) paradigm

Full Title of Study: “D-serine and Cognitive Remediation in Schizophrenia: Open Label Pilot”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

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

Interventions

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

Arms, Groups and Cohorts

  • Experimental: D-serine
    • D-serine

Clinical Trial Outcome Measures

Primary Measures

  • Mismatch Negativity (MMN)
    • Time Frame: 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 Measures

  • Tone Matching Threshold
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nathan Kline Institute for Psychiatric Research
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joshua T Kantrowitz, MD, Principal Investigator, Nathan Kline Institute

Citations Reporting on Results

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.

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