Phase 2
N=16
Biomarkers in Schizophrenia
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00817336 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: PANSS Total — 77.9; 80 units on a scale — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- D Serine (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nathan Kline Institute for Psychiatric Research
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PANSS Total |
77.9; 80 | 0.02 sig |
| PRIMARY MMN Amplitude |
-1.21; -.21 | 0.001 sig |
| SECONDARY MATRICS |
26.2; 25.7 | .31 |
| SECONDARY Visual P1 |
-.21; -.54 | .41 |
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.
Eligibility Criteria
Inclusion criteria
- Age 18-64
- SCID diagnosis of Schizophrenia or Schizoaffective Disorder.
- PANSS 3 factor negative symptom (screening and baseline visit 1 and visit 3) score of >20 and PANSS total score between 60-110. Any degree of positive symptoms is acceptable but the total PANSS score must not exceed 110.
- SAS total score less than or equal to 12 and a Calgary Depression Inventory total score less than or equal to 10 and suicide (item 8) less than moderate (<2).
- Two consecutive CGI ratings at screening and baseline (visit 1 and 3) with no change in score.
- Estimated Glomerular Filtration Rate (GFR)(a measure of renal function) greater than or equal to 60.
Exclusion criteria
- Organic brain disorder, including epilepsy; mental retardation; or a medical condition whose pathology or treatment would likely alter the presentation or treatment of schizophrenia or significantly increase the risk associated with any of the proposed treatments
- Current DSM-IV diagnosis of drug/alcohol abuse in last month and current DSM-IV diagnosis of drug/alcohol dependence in last 6 months
- Pregnant female patients
- Impaired renal function
- Significant extrapyramidal symptoms (as reflected by a total score of 10 or above on the SAS scale), and depressive symptoms (as reflected by a score of 10 or above on the Calgary Depression Scale for Schizophrenia)
- Patients who are unable to or unwilling to participate in the Cognitive assessment (MATRICS) and the electrophysiology tasks .
- Patients on clozapine
Data sourced from ClinicalTrials.gov (NCT00817336). 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.