D-amino Acid Oxidase Inhibition (DAAOI-1) add-on Treatment for Chronic Schizophrenia
|ClinicalTrials.gov Identifier: NCT00960219|
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : July 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenias Psychoses Psychotic Disorders Schizophrenic Disorders||Drug: D-amino acid oxidase inhibition (DAAOI-1) Drug: placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||D-amino Acid Oxidase Inhibition for NMDA Modulation in Schizophrenia|
|Study Start Date :||April 2009|
|Primary Completion Date :||July 2011|
|Study Completion Date :||July 2011|
Drug: D-amino acid oxidase inhibition (DAAOI-1)
1g/day(500mg BID), oral, for 6 weeks
Other Name: DAAOI-1
|Placebo Comparator: placebo||
1# BID, oral, for 6 weeks
Other Name: starch
- Total scores of PANSS, SANS, GAF, and QOL [ Time Frame: week 0, 2, 4, 6. ]
- Cognitive function [ Time Frame: Week 0, 6 ]MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia), including:1) speed of processing;(2) sustained attention; 3) working memory, verbal and nonverbal; 4) verbal learning and memory; 5) visual learning and memory; 6) reasoning and problem solving, and 7) social cognition
- The subscales of PANSS [ Time Frame: week 0,2,4,6 ]
- Hamilton Depression rating scale 17(HAM-D 17) [ Time Frame: Week 0, 2, 4, 6 ]
- Clinical Global Impression(CGI) [ Time Frame: Week 0, 2, 4, 6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960219
|Department of Psychiatry, China Medical University Hospital|
|Principal Investigator:||Hsien-Yuan Lane, M.D., Ph.D||Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan|