Psychotic Disorders Clinical Trial
Official title:
D-amino Acid Oxidase Inhibition for NMDA Modulation in Schizophrenia
Adjuvant N-methyl-D-aspartic acid (NMDA)-enhancing agents, such as GlyT-1 inhibitors and NMDA-glycine site agonists have been demonstrated to be beneficial for chronic schizophrenia patients. The purpose of this study is to evaluate efficacy and safety of add-on treatment of an inhibitor of D-amino acid oxidase (DAAOI), DAAOI-1, in chronically stable schizophrenia patients who have been stabilized with antipsychotics.
The etiology of schizophrenia remains unclear. Schizophrenia patients reveal positive
symptoms, negative symptoms, and cognitive impairments. In addition to dopamine system
hyperactivity, hypofunction of N-methyl-D-aspartate (NMDA) receptor plays a role in the
pathophysiology of schizophrenia. Consequently, enhancing NMDA receptor neurotransmission
has been regarded as a novel treatment approach. To date, several reported trials on
adjuvant NMDA-enhancing agents, including glycine, D-amino acids (D-serine, D-alanine), and
sarcosine (a glycine transporter I inhibitor), revealed beneficial but limited efficacy for
positive and negative symptoms.
DAAOI-1 is a D-amino acid oxidase (DAAO) inhibitor which can elevate synaptic concentration
of D-amino acids. The aim of this project is to examine the efficacy and safety of add-on
treatment of DAAOI-1 in chronically stable schizophrenia patients who have been stabilized
with antipsychotics.
In the study, 60 schizophrenic patients are recruited into the 6-week trial and randomly
assigned into the two groups (1 gm/dDAAOI-1, or placebo) with a double-blind manner.
Positive and Negative Syndrome Scale (PANSS), Scales for the Assessment of Negative symptoms
(SANS), Global Assessment of Function (GAF), quality of life (QOL), Hamilton Depression
rating scale 17(HAM-D 17), Clinical Global Impression(CGI)and side effects are evaluated
every two weeks during the trial. Cognitive function ("7 domains of Measurement and
Treatment Research to Improve Cognition in Schizophrenia" [MATRICS])are assessed at weeks 0
and 6. The efficacies of two groups are compared.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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