Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia 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-2, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing agent. The aim of this project is to examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment-resistant 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 is still a difficult clinical issue at present. 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 such as D-serine, and sarcosine (a glycine transporter I inhibitor), revealed beneficial but limited efficacy for positive and negative symptoms. The aim of this project is to examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment resistant schizophrenia patients in a randomized, double-blind, placebo - controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan
Positive and Negative Syndrome Scale(PANSS)
Time frame: baseline
Positive and Negative Syndrome Scale(PANSS)
Time frame: 2 weeks after the trial
Positive and Negative Syndrome Scale(PANSS)
Time frame: 4 weeks after the trial
Positive and Negative Syndrome Scale(PANSS)
Time frame: 6 weeks after the trial (The end of the trial)
Assessment of Negative symptoms(SANS)
Time frame: baseline
Assessment of Negative symptoms(SANS)
Time frame: 2 weeks after the trial
Assessment of Negative symptoms(SANS)
Time frame: 4 weeks after the trial
Assessment of Negative symptoms(SANS)
Time frame: 6 weeks after the trial (The end of the trial)
PANSS subscales
Time frame: baseline
PANSS subscales
Time frame: 2 weeks after the trial
PANSS subscales
Time frame: 4 weeks after the trial
PANSS subscales
Time frame: 6 weeks after the trial (The end of the trial)
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Clinical Global Impression (CGI)
Time frame: baseline
Clinical Global Impression (CGI)
Time frame: 2 weeks after the trial
Clinical Global Impression (CGI)
Time frame: 4 weeks after the trial
Clinical Global Impression (CGI)
Time frame: 6 weeks after the trial (The end of the trial)
Global assessment of function (GAF)
Time frame: baseline
Global assessment of function (GAF)
Time frame: 2 weeks after the trial
Global assessment of function (GAF)
Time frame: 4 weeks after the trial
Global assessment of function (GAF)
Time frame: 6 weeks after the trial (The end of the trial)
Hamilton Depression Rating Scale (HAMD)
Time frame: baseline
Hamilton Depression Rating Scale (HAMD)
Time frame: 2 weeks after the trial
Hamilton Depression Rating Scale (HAMD)
Time frame: 4 weeks after the trial
Hamilton Depression Rating Scale (HAMD)
Time frame: 6 weeks after the trial (The end of the trial)
Quality of life scale (QOL)
Time frame: baseline
Quality of life scale (QOL)
Time frame: 2 weeks after the trial
Quality of life scale (QOL)
Time frame: 4 weeks after the trial
Quality of life scale (QOL)
Time frame: 6 weeks after the trial (The end of the trial)
"Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS]
An intergrated score from 7 domains: 1. speed of processing: category fluency, trail making A, and digit symbol - coding from Wechsler adult intelligence scale (WAIS-III); 2. sustained attention: continuous performance test; 3. verbal and nonverbal working memory: backward digit span and spatial span from Wechsler memory scale (WMS-III); 4. verbal learning and memory: word listing from WMS-III; 5. visual learning and memory: visual reproduction from WMS-III; 6. reasoning and problem solving: maze from Wechsler intelligence scale for children (WISC-III); 7. social cognition: the managing emotions branch of Mayer-Salovey-Caruso emotional intelligence test (MSCEIT)
Time frame: baseline
"Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS]
An intergrated score from 7 domains: 1. speed of processing: category fluency, trail making A, and digit symbol - coding from Wechsler adult intelligence scale (WAIS-III); 2. sustained attention: continuous performance test; 3. verbal and nonverbal working memory: backward digit span and spatial span from Wechsler memory scale (WMS-III); 4. verbal learning and memory: word listing from WMS-III; 5. visual learning and memory: visual reproduction from WMS-III; 6. reasoning and problem solving: maze from Wechsler intelligence scale for children (WISC-III); 7. social cognition: the managing emotions branch of Mayer-Salovey-Caruso emotional intelligence test (MSCEIT)
Time frame: 6 weeks after the trial (The end of the trial)