Biomarkers in Schizophrenia

Phase 2

Completed

• Conditions: Schizoaffective Disorder; Schizophrenia
• Interventions: Drug: D Serine; Drug: Placebo

• Registration Number: NCT00817336
• Lead Sponsor: Nathan Kline Institute for Psychiatric Research

Brief Summary

N-methyl-D-aspartate (NMDA)-type glutamate receptors are thought to play a pivotal role in neurocognitive dysfunction associated with schizophrenia. Further, several novel glutamate-based classes of compound are presently in development as potential novel treatments for persistent negative and cognitive symptoms. The study will assess effectiveness of a NMDA-based intervention on biomarkers related to schizophrenia as a mechanism for developing appropriate outcome batteries for future trials of novel compounds.

Detailed Description

16 in- or outpatients with DSM-IV-TR schizophrenia or schizoaffective disorder and prominent negative symptoms will be recruited for this study. This study will consist of a randomized trial of D-serine (60 mg/kg/d) vs. placebo using a crossover design with a 2-week baseline lead-in, and two 6-week intervention arms separated by a two week, placebo controlled washout period. Biomarkers will be assessed at baseline for each treatment arm, acutely (day 7) following treatment initiation, and following 6 weeks of treatment (6 biomarker sessions total). Primary biomarker outcome measures will include 1) amplitude of the mismatch negativity (MMN) waveform and 2) amplitude of the visual P1 potential. Symptomatic outcome measures will include PANSS and composite score of the MATRICS neuropsychological battery. The study will be supported from ongoing NIMH-funded Cooperative Drug Development Grant (CDDG) to the PI.

Study Timeline

• Study First Submitted: 2009-01-05
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Study Start: 2009-06
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2016-12-15
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-07
• Last Update Submitted: 2017-07-07
• Results First Posted: 2017-08-02
• Last Update Posted: 2017-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
D-serine	D Serine	60 mg/kg/day
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
PANSS Total	6 weeks	Positive and Negative Symptom Scale (PANSS) range 30-210
MMN Amplitude	6 weeks	Final MMN amplitude

Secondary Outcome Measures

Name	Time	Method
Visual P1	6 weeks
MATRICS	6 weeks	MATRICS assessing 7 domains (Speed of Processing, Attention/Vigilance, Working Memory, Verbal Learning, Visual Learning, Reasoning and Problem Solving, and Social Cognition. Raw scores are converted into a composite T-score (normative mean = 50; standard deviation = 10), where higher values indicated less impairment.

Trial Locations

Locations (1)

Nathan Kline Institute; 🇺🇸 Orangeburg, New York, United States