DAAOI-2 add-on Treatment for Treatment-resistant Schizophrenia
- Registration Number
- NCT02532686
- Lead Sponsor
- China Medical University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Fulfill the DSM-IV criteria of schizophrenia
- Treatment resistant: No satisfactory response to at least two kinds of antipsychotics
- Remain symptomatic but without clinically significant fluctuation and the antipsychotic doses are unchanged for at least 3 months
- Have a minimum baseline total score of 70 on the Positive and Negative Syndrome Scale (PANSS)
- Agree to participate in the study and provide informed consent
- Meet DSM-IV criteria of substance (including alcohol) abuse or dependence
- Meet DSM-IV criteria of mental retardation
- Serious medical or neurological illness
- Pregnancy or lactation
- Inability to follow protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DAAOI-2 DAAOI-2 DAAOI-2: 500-2000mg/d placebo placebo -
- Primary Outcome Measures
Name Time Method Positive and Negative Syndrome Scale(PANSS) 6 weeks after the trial (The end of the trial) Assessment of Negative symptoms(SANS) 6 weeks after the trial (The end of the trial)
- Secondary Outcome Measures
Name Time Method Clinical Global Impression (CGI) 6 weeks after the trial (The end of the trial) Quality of life scale (QOL) 6 weeks after the trial (The end of the trial) Hamilton Depression Rating Scale (HAMD) 6 weeks after the trial (The end of the trial) "Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS] 6 weeks after the trial (The end of the trial) 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)Global assessment of function (GAF) 6 weeks after the trial (The end of the trial) PANSS subscales 6 weeks after the trial (The end of the trial)
Trial Locations
- Locations (1)
Department of Psychiatry, China Medical University Hospital
🇨🇳Taichung, Taiwan