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NCT Number: NCT01390376

DAAOI-1 Treatment for Treatment-resistant Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

About this study

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. Among schizophrenia patients, around 20-25%are treatment-resistant. According to the N-methyl-D-aspartate (NMDA) hypothesis, many clinical trials on NMDA-enhancing agents were studied. Adjuvant NMDA-enhancing agents, including glycine, D-amino acids (D-serine, D-alanine), and sarcosine (a glycine transporter I inhibitor), revealed beneficial but limited efficacy for positive and negative symptoms. The investigators recently started to study the potential of DAAOI-1, a D-amino acid oxidase (DAAO) inhibitor which can elevate synaptic concentration of D-amino acids.

The aims 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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DAAOI-1

Drug

DAAOI-1 1g

Placebo

Drug

starch pill

Primary outcomes

  1. The severity of psychiatric symptoms

    Time frame: week 0, 2, 4, 6

    The severity of psychiatric symptoms will be assessed by:

    • Positive and Negative Syndrome Scale(PANSS)
    • Assessment of Negative symptoms(SANS)
    • Global assessment of function(GAF)
    • Quality of life scale(QOL)

Secondary outcomes

  1. PANSS subscales

    Time frame: week 0,2,4,6

    score changes

  2. Hamilton Depression Rating Scale (HAMD)

    Time frame: Week 0,2,4, 6

  3. Cognitive function

    Time frame: week 0, 6

    7 domains of Measurement and Treatment Research to Improve Cognition in Schizophrenia" [MATRICS]

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Collaborators

  • Department of Health, Executive Yuan, R.O.C. (Taiwan)

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 11, 2011
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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