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CompletedNCT02532686Updated Jan 30, 2018

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

A Phase 2 interventional study of DAAOI-2 and placebo in Schizophrenia, sponsored by China Medical University Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by China Medical University Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Schizophrenia

Keywords

  • Treatment resistant
  • DAAOI
  • NMDA
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.

This study's enrollment of 40 is below the median of 70 across 2,871 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    DAAOI-2

    DAAOI-2: 500-2000mg/d

    Drug: DAAOI-2

  • Placebo comparator
    placebo

    Drug: placebo

Interventions

  • DrugDAAOI-2

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

  • Drugplacebo

    oral, for 6 weeks

06

What researchers measure

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]

    An intergrated score from 7 domains: 1. speed of processing: category fluency, trail making A, and digit symbol - coding from Wechsler adult intelligence scale (WAIS-III); 2. sustained attention: continuous performance test; 3. verbal and nonverbal working memory: backward digit span and spatial span from Wechsler memory scale (WMS-III); 4. verbal learning and memory: word listing from WMS-III; 5. visual learning and memory: visual reproduction from WMS-III; 6. reasoning and problem solving: maze from Wechsler intelligence scale for children (WISC-III); 7. social cognition: the managing emotions branch of Mayer-Salovey-Caruso emotional intelligence test (MSCEIT)

    Time frame: baseline

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

    An intergrated score from 7 domains: 1. speed of processing: category fluency, trail making A, and digit symbol - coding from Wechsler adult intelligence scale (WAIS-III); 2. sustained attention: continuous performance test; 3. verbal and nonverbal working memory: backward digit span and spatial span from Wechsler memory scale (WMS-III); 4. verbal learning and memory: word listing from WMS-III; 5. visual learning and memory: visual reproduction from WMS-III; 6. reasoning and problem solving: maze from Wechsler intelligence scale for children (WISC-III); 7. social cognition: the managing emotions branch of Mayer-Salovey-Caruso emotional intelligence test (MSCEIT)

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

07

Study locations

1 site
  • Department of Psychiatry, China Medical University Hospital
    Taichung, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02532686
Lead sponsor
China Medical University Hospital
Collaborators
Ministry of Science and Technology, Taiwan
Responsible party
Hsien-Yuan Lane (Department of Psychiatry, China Medical University Hospital) — Principal investigator
First posted
Aug 26, 2015
Start date
Oct 2014
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Jan 30, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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