Psychotic Disorders Clinical Trial
Official title:
D-amino Acid Oxidase Inhibition for NMDA Modulation in Schizophrenia
Verified date | July 2011 |
Source | China Medical University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Are physically healthy and have all laboratory assessments (including urine/blood routine, biochemical tests, and electrocardiograph) within normal limits - Aged 18-65 year - Fulfill the criteria of schizophrenia according to the Diagnostic and Statistical Manual, fourth edition (DSM-IV) - 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 60 on the Positive and Negative Syndrome Scale (PANSS) - Agree to participate in the study and provide informed consent Exclusion Criteria: - DSM-IV diagnosis of substance (including alcohol) abuse or dependence, - DSM_IV diagnosis of mental retardation - History of epilepsy, head trauma or CNS diseases - History of epilepsy, head trauma or CNS diseases - Pregnancy or lactation - Inability to follow protocol |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of Psychiatry, China Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
China Medical University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total scores of PANSS, SANS, GAF, and QOL | week 0, 2, 4, 6. | Yes | |
Primary | Cognitive function | 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 | Week 0, 6 | No |
Secondary | The subscales of PANSS | week 0,2,4,6 | Yes | |
Secondary | Hamilton Depression rating scale 17(HAM-D 17) | Week 0, 2, 4, 6 | No | |
Secondary | Clinical Global Impression(CGI) | Week 0, 2, 4, 6 | No |
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