D-serine and Cognitive Remediation in Schizophrenia

NCT02156908 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 601945
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Schizophrenia

Keywords

cognitive remediation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tone Matching Threshold

  three weeks

Study Arms (1)

D-serine

EXPERIMENTAL

D-serine

Drug: D-serine

Interventions

D-serine DRUG

D-serine 60 mg/kg

D-serine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nathan Kline Institute for Psychiatric Research: lead

Study Sites (1)

Nathan Kline Institute

Orangeburg, New York, 10962, United States

Location

Related 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 agonist D-serine. Brain. 2016 Dec;139(Pt 12):3281-3295. doi: 10.1093/brain/aww262.

  PMID: 27913408 RESULT

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Joshua Kantrowitz
• Organization: Nathan Kline Institute

josh.kantrowitz@nki.rfmh.org

646-774-6738

Study Officials

• Joshua T Kantrowitz, MD

  Nathan Kline Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 5, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-09

Locations

US (1)