CompletedPhase 2

DAAOI-1 Treatment for Treatment-resistant Schizophrenia

Taiwan60 participantsStarted 2010-09

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

The severity of psychiatric symptoms

Timeframe: week 0, 2, 4, 6

Trial details

NCT IDNCT01390376

SponsorChina Medical University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09

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