Schizophrenia Clinical Trial
Official title:
GlyT-1 Inhibitor Treatment for Refractory Schizophrenia and Its Effects on NMDA Modulation
The etiology of schizophrenia remains unclear In recent one decade, hypofunction of
N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of
schizophrenia. Hence, enhancing NMDA neurotransmission was considered as a new approach for
schizophrenia treatment.
To date, refractory schizophrenia (particularly clozapine-resistant) is still a difficult
clinical issue. However, the effect of NMDA treatment in refractory schizophrenia is still
unknown. Therefore, the primary goal of this study is to investigate the efficacy and safety
of NMDA adjuvant therapy in refractory schizophrenia, and to identify the predictors for
treatment response to NMDA enhancers.
The etiology of schizophrenia remains unclear. In recent one decade, hypofunction of
N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of
schizophrenia. Hence, enhancing NMDA neurotransmission was considered as a new approach for
schizophrenia treatment. To date, there have been a few pilot studies exploring the efficacy
of NMDA enhancers as adjuvant therapy for schizophrenia, for instance, D-serine (an
endogenous agonist of the NMDA-glycine site). They were not only well-tolerated but also
synergistic in improving positive, negative and cognitive symptoms in those receiving
typical and atypical antipsychotics (except clozapine).
Refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical
issue at present. Previous studies revealed that add-on treatment of D-serine or other
agonists of NMDA receptor failed to give significant benefits in such patients. The primary
goal of this study is to investigate the efficacy and safety of glycine transporter(GlyT)-1
inhibitor adjuvant therapy in refractory schizophrenia, and to identify the predictors for
treatment response to NMDA enhancers.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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