Phase 2
Completed N=8
D-serine and Cognitive Remediation in Schizophrenia
Source: ClinicalTrials.gov NCT02156908 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Mismatch Negativity (MMN) — .086; 0.31 micro volts
Summary
The investigators will test the effects of 3 days of D-serine (DSR) on auditory plasticity in a sensory based remediation (SBR) paradigm
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mismatch Negativity (MMN) |
.086; 0.31 | — |
| SECONDARY Tone Matching Threshold |
11; 2.3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02156908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.