Schizophrenia Clinical Trial
Official title:
DAAOI-1 Treatment for Treatment-resistant Schizophrenia
Pharmacotherapy for schizophrenia has limitations such as residual positive and negative
symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia
(particularly clozapine-resistant) is still a difficult clinical issue at present. According
to the N-methyl-D-aspartate (NMDA) hypothesis, adjuvant NMDA-enhancing agents may have
therapeutic benefit. DAAOI-1, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing
agents.
The aim of this project is to examine the effectiveness and safety of DAAOI-1 adjuvant
treatment for clozapine-resistant refractory schizophrenia patients in a randomized,
double-blind, placebo - controlled trial.
Pharmacotherapy for schizophrenia has limitations such as residual positive and negative
symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia
(particularly clozapine-resistant) is still a difficult clinical issue at present. Among
schizophrenia patients, around 20-25%are treatment-resistant. According to the
N-methyl-D-aspartate (NMDA) hypothesis, many clinical trials on NMDA-enhancing agents were
studied. 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. The investigators recently started to
study the potential of DAAOI-1, a D-amino acid oxidase (DAAO) inhibitor which can elevate
synaptic concentration of D-amino acids.
The aims of this project is to examine the effectiveness and safety of DAAOI-1 adjuvant
treatment for clozapine-resistant refractory schizophrenia patients in a randomized,
double-blind, placebo - controlled trial.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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