Phase 3 N=104 Randomized Triple-blind Treatment

D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia

Schizophrenia · Schizoaffective Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00237809 ↗

Enrolled (actual)

104

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Wisconsin Card Sorting Test (WCST) — 38.43; 35.79; 43.14; 39.57 percentage of correct responses

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: D-serine (Drug); Cognitive Retraining (CRT) (Behavioral); Placebo (Drug); Cognitive Retraining Placebo (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Wisconsin Card Sorting Test (WCST)	38.43; 35.79; 43.14; 39.57	—
PRIMARY Hopkins Verbal Learning Test	20.74; 19.80; 20.42; 21.45	—
PRIMARY Spatial Span- Total Score	13.59; 13.88; 13.21; 13.58	—
PRIMARY Positive and Negative Syndrome Scale (PANSS)	53.30; 52.01; 53.79; 53.96	—
SECONDARY Heinrichs-Carpenter Quality of Life Scale	67.26; 68.30; 63.25; 63.92	—
SECONDARY Simpson-Angus Neurological Rating Scale	1.41; 0.72; 1.04; 1.81	—
SECONDARY UCSD Performance-Based Skills Assessment (UPSA)	34.19; 32.80; 32.60; 31.39	—

Summary

This study is based on the hypothesis that by increasing N-methyl-D-aspartic acid (NMDA) receptor function in the brain and thereby increasing the capacity of the brain to both form new connections and strengthen existing connections, schizophrenic patients may derive both greater and sustained benefit from cognitive retraining.

Eligibility Criteria

Inclusion Criteria

Diagnosis of schizophrenia or schizoaffective disorder

Exclusion

Pregnant or lactating

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00237809). 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.