Phase 2
N=45
D-serine Augmentation of Neuroplasticity
Schizophrenia · Schizo Affective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03711500 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Plasticity Improvement (Change in Tone Matching Threshold) — 13.9; 5.3; 11; -0.05 log ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- D-serine (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasticity Improvement (Change in Tone Matching Threshold) |
13.9; 5.3; 11; -0.05 | — |
| PRIMARY Mismatch Negativity (MMN) |
-1.83; -1.05; -2.71; -0.56 | — |
| PRIMARY Theta Intertrial Coherence (Theta) |
.229; .241; 0.274; .241 | — |
| PRIMARY Number of Patients With Granular Casts |
0; 0; 0; 0 | — |
Summary
Schizophrenia is a major public health problem associated with cognitive deficits, such as short and long term memory, executive functioning, attention and speed of processing that are amongst the strongest predictors of impaired functional outcome. In addition, schizophrenia patients show reduced "plasticity", defined as reduced learning.
D-serine is a naturally occurring activator of the N-methyl-d-aspartate-type glutamate receptors (NMDAR) in the brain, and this project will assess the optimal dose of D-serine treatment over three sessions of a program designed to measure auditory plasticity.
Eligibility Criteria
Inclusion Criteria
- Age between 18 and 50
- DSM-V diagnosis of schizophrenia or schizoaffective disorder
- Willing to provide informed consent
- Auditory Cognitive impairment demonstrated by:
a .MCCB composite domain score less than or equal to 0.5 standard deviation below normal (T score less than or equal to 45) b. And at least one of the following:
- MCCB verbal memory domain score less than or equal to 0.5 standard deviation below normal (T score less than or equal to 45)
- Tone matching score of less than or equal to 77.7%
- Clinically stable for 2 months (CGI less than or equal to 4)
- Moderate or lower cognitive disorganization (PANSS P2 less than or equal to 4)
- Medically stable for study participation
- Willing to use qualified methods of contraception for the study duration and up to 2 months after its end
- Fluent English speaker
- Normal hearing
- Visual acuity corrected to 20/30
- An estimated Glomerular Filtration Rate (GFR) greater than or equal to 60
- Taking an antipsychotic medication other than clozapine at a stable dose for at least 4 weeks
- Judged clinically not to be at significant suicide or violence risk
Exclusion Criteria
- ECG abnormality that is clinically significant in the context of study participation in the opinion of the study cardiologist
- Current clozapine use
- Presence of positive history of unstable significant medical or neurological illness
- Positive toxicology screen for any substances of abuse
- Substance use disorder (excluding nicotine) within last 60 days
- Pregnant women or women of child-bearing potential, who are either not surgically-sterile or for outpatients, using appropriate methods of birth control. Women of childbearing potential must have a negative serum -hCG pregnancy test at every visit.
- Participation in study of investigational medication/device within 4 weeks
- Subjects with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the investigator Section
Data sourced from ClinicalTrials.gov (NCT03711500). 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.