Status:
COMPLETED
Biomarkers in Schizophrenia
Lead Sponsor:
Nathan Kline Institute for Psychiatric Research
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
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 c...
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-seri...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00817336
Start Date
June 1 2009
End Date
July 1 2011
Last Update
August 2 2017
Active Locations (1)
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1
Nathan Kline Institute
Orangeburg, New York, United States, 10962