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Completed

NCT Number: NCT02532686

DAAOI-2 add-on 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 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.

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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 is still a difficult clinical issue at present. 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 such as D-serine, and sarcosine (a glycine transporter I inhibitor), revealed beneficial but limited efficacy for positive and negative symptoms.

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

DAAOI-2

Drug

500-2000mg/d, oral, for 6 weeks

Placebo

Drug

oral, for 6 weeks

Primary outcomes

  1. Positive and Negative Syndrome Scale(PANSS)

    Time frame: baseline

  2. Positive and Negative Syndrome Scale(PANSS)

    Time frame: 2 weeks after the trial

  3. Positive and Negative Syndrome Scale(PANSS)

    Time frame: 4 weeks after the trial

  4. Positive and Negative Syndrome Scale(PANSS)

    Time frame: 6 weeks after the trial (The end of the trial)

  5. Assessment of Negative symptoms(SANS)

    Time frame: baseline

  6. Assessment of Negative symptoms(SANS)

    Time frame: 2 weeks after the trial

  7. Assessment of Negative symptoms(SANS)

    Time frame: 4 weeks after the trial

  8. Assessment of Negative symptoms(SANS)

    Time frame: 6 weeks after the trial (The end of the trial)

Secondary outcomes

  1. PANSS subscales

    Time frame: baseline

  2. PANSS subscales

    Time frame: 2 weeks after the trial

  3. PANSS subscales

    Time frame: 4 weeks after the trial

  4. PANSS subscales

    Time frame: 6 weeks after the trial (The end of the trial)

  5. Clinical Global Impression (CGI)

    Time frame: baseline

  6. Clinical Global Impression (CGI)

    Time frame: 2 weeks after the trial

  7. Clinical Global Impression (CGI)

    Time frame: 4 weeks after the trial

  8. Clinical Global Impression (CGI)

    Time frame: 6 weeks after the trial (The end of the trial)

  9. Global assessment of function (GAF)

    Time frame: baseline

  10. Global assessment of function (GAF)

    Time frame: 2 weeks after the trial

  11. Global assessment of function (GAF)

    Time frame: 4 weeks after the trial

  12. Global assessment of function (GAF)

    Time frame: 6 weeks after the trial (The end of the trial)

  13. Hamilton Depression Rating Scale (HAMD)

    Time frame: baseline

  14. Hamilton Depression Rating Scale (HAMD)

    Time frame: 2 weeks after the trial

  15. Hamilton Depression Rating Scale (HAMD)

    Time frame: 4 weeks after the trial

  16. Hamilton Depression Rating Scale (HAMD)

    Time frame: 6 weeks after the trial (The end of the trial)

  17. Quality of life scale (QOL)

    Time frame: baseline

  18. Quality of life scale (QOL)

    Time frame: 2 weeks after the trial

  19. Quality of life scale (QOL)

    Time frame: 4 weeks after the trial

  20. Quality of life scale (QOL)

    Time frame: 6 weeks after the trial (The end of the trial)

  21. "Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS]

    Time frame: baseline

    An intergrated score from 7 domains:

    • speed of processing: category fluency, trail making A, and digit symbol - coding from Wechsler adult intelligence scale (WAIS-III);
    • sustained attention: continuous performance test;
    • verbal and nonverbal working memory: backward digit span and spatial span from Wechsler memory scale (WMS-III);
    • verbal learning and memory: word listing from WMS-III;
    • visual learning and memory: visual reproduction from WMS-III;
    • reasoning and problem solving: maze from Wechsler intelligence scale for children (WISC-III);
    • social cognition: the managing emotions branch of Mayer-Salovey-Caruso emotional intelligence test (MSCEIT)

  22. "Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS]

    Time frame: 6 weeks after the trial (The end of the trial)

    An intergrated score from 7 domains:

    • speed of processing: category fluency, trail making A, and digit symbol - coding from Wechsler adult intelligence scale (WAIS-III);
    • sustained attention: continuous performance test;
    • verbal and nonverbal working memory: backward digit span and spatial span from Wechsler memory scale (WMS-III);
    • verbal learning and memory: word listing from WMS-III;
    • visual learning and memory: visual reproduction from WMS-III;
    • reasoning and problem solving: maze from Wechsler intelligence scale for children (WISC-III);
    • social cognition: the managing emotions branch of Mayer-Salovey-Caruso emotional intelligence test (MSCEIT)

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Collaborators

  • Ministry of Science and Technology, Taiwan

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 26, 2015
Registry last updated
Jan 30, 2018

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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