D-amino Acid Oxidase Inhibition (DAAOI-1) add-on Treatment for Chronic Schizophrenia

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University Hospital

Criteria

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