DAAOI-1 Treatment for Treatment-resistant Schizophrenia

• Status: Completed
• Trial end date: 2014-09-01
• 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 (particularly clozapine-resistant) 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-1, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing agents.

The aim of this project is to examine the effectiveness and safety of DAAOI-1 adjuvant treatment for clozapine-resistant refractory 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: Department of Health, Executive Yuan, R.O.C. (Taiwan)

Criteria

Inclusion Criteria:

• Fulfilled the DSM-IV criteria of schizophrenia

• Poor responder of clozapine: a 12-week treatment without satisfactory response: a minimal total score of 70 on the Positive and Negative Syndrome Scale (PANSS) (Kay 1987), and a minimal total score of 40 on the Scale for the Assessment of Negative Symptoms (SANS) (Andreasen 1983).

• Agree to participate in the study and provide informed consent

Exclusion Criteria:

• Meet DSM-IV criteria of other AXIS I disorder, current substance dependence or mental retardation

• Serious medical or neurological illness

• Pregnancy or lactation

• Use of depot antipsychotic in the past 6 months

• Inability to follow protocol.