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D-serine and Cognitive Remediation in Schizophrenia

N

Nathan Kline Institute for Psychiatric Research

Status and phase

Completed
Phase 2

Conditions

Schizophrenia

Treatments

Drug: D-serine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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

Enrollment

8 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

D-serine
Experimental group
Description:
D-serine
Treatment:
Drug: D-serine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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