Biomarkers in Schizophrenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT00817336

Run by

Nathan Kline Institute for Psychiatric Research

People needed

16

Starts

2009-06-01

Expected to finish

2011-07-01

Last updated by the study team

2017-08-02

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Nathan Kline Institute — Orangeburg, New York, United States

Full record on ClinicalTrials.gov

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