DAAOI-2 add-on Treatment for Treatment-resistant Schizophrenia

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: China Medical University Hospital
• Collaborator: Ministry of Science and Technology, Taiwan

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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