D-serine and Cognitive Remediation in Schizophrenia

Schizophrenia Clinical Trial

Official title:

D-serine and Cognitive Remediation in Schizophrenia: Open Label Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156908
• Other study ID #: 601945
• Status: Completed
• Phase: Phase 2
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2020
• Source: Nathan Kline Institute for Psychiatric Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• D-serine
D-serine 60 mg/kg

Locations

Country	Name	City	State
United States	Nathan Kline Institute	Orangeburg	New York

Sponsors (1)

Lead Sponsor	Collaborator
Nathan Kline Institute for Psychiatric Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 ago — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks
Secondary	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	three weeks