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D-amino Acid Oxidase Inhibition (DAAOI-1) add-on Treatment for Chronic Schizophrenia

Sponsor
China Medical University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00960219
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
27
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Adjuvant N-methyl-D-aspartic acid (NMDA)-enhancing agents, such as GlyT-1 inhibitors and NMDA-glycine site agonists have been demonstrated to be beneficial for chronic schizophrenia patients. The purpose of this study is to evaluate efficacy and safety of add-on treatment of an inhibitor of D-amino acid oxidase (DAAOI), DAAOI-1, in chronically stable schizophrenia patients who have been stabilized with antipsychotics.

Condition or Disease Intervention/Treatment Phase
  • Drug: D-amino acid oxidase inhibition (DAAOI-1)
  • Drug: placebo
 Phase 2

Detailed Description

The etiology of schizophrenia remains unclear. Schizophrenia patients reveal positive symptoms, negative symptoms, and cognitive impairments. In addition to dopamine system hyperactivity, hypofunction of N-methyl-D-aspartate (NMDA) receptor plays a role in the pathophysiology of schizophrenia. Consequently, enhancing NMDA receptor neurotransmission has been regarded as a novel treatment approach. To date, several reported trials on 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.

DAAOI-1 is a D-amino acid oxidase (DAAO) inhibitor which can elevate synaptic concentration of D-amino acids. The aim of this project is to examine the efficacy and safety of add-on treatment of DAAOI-1 in chronically stable schizophrenia patients who have been stabilized with antipsychotics.

In the study, 60 schizophrenic patients are recruited into the 6-week trial and randomly assigned into the two groups (1 gm/dDAAOI-1, or placebo) with a double-blind manner. Positive and Negative Syndrome Scale (PANSS), Scales for the Assessment of Negative symptoms (SANS), Global Assessment of Function (GAF), quality of life (QOL), Hamilton Depression rating scale 17(HAM-D 17), Clinical Global Impression(CGI)and side effects are evaluated every two weeks during the trial. Cognitive function ("7 domains of Measurement and Treatment Research to Improve Cognition in Schizophrenia" [MATRICS])are assessed at weeks 0 and 6. The efficacies of two groups are compared.

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
D-amino Acid Oxidase Inhibition for NMDA Modulation in Schizophrenia
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: DAAOI-1

Drug: D-amino acid oxidase inhibition (DAAOI-1)
1g/day(500mg BID), oral, for 6 weeks
Other Names:
  • DAAOI-1

    		•
    Placebo Comparator: placebo

    Drug: placebo
    1# BID, oral, for 6 weeks
    Other Names:
  • starch

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total scores of PANSS, SANS, GAF, and QOL [week 0, 2, 4, 6.]

    2. Cognitive function [Week 0, 6]

      MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia), including:1) speed of processing;(2) sustained attention; 3) working memory, verbal and nonverbal; 4) verbal learning and memory; 5) visual learning and memory; 6) reasoning and problem solving, and 7) social cognition

    Secondary Outcome Measures

    1. The subscales of PANSS [week 0,2,4,6]

    2. Hamilton Depression rating scale 17(HAM-D 17) [Week 0, 2, 4, 6]

    3. Clinical Global Impression(CGI) [Week 0, 2, 4, 6]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Are physically healthy and have all laboratory assessments (including urine/blood routine, biochemical tests, and electrocardiograph) within normal limits

    • Aged 18-65 year

    • Fulfill the criteria of schizophrenia according to the Diagnostic and Statistical Manual, fourth edition (DSM-IV)

    • 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 60 on the Positive and Negative Syndrome Scale (PANSS)

    • Agree to participate in the study and provide informed consent

    Exclusion Criteria:

    • DSM-IV diagnosis of substance (including alcohol) abuse or dependence,

    • DSM_IV diagnosis of mental retardation

    • History of epilepsy, head trauma or CNS diseases

    • History of epilepsy, head trauma or CNS diseases

    • Pregnancy or lactation

    • Inability to follow protocol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Psychiatry, China Medical University Hospital Taichung Taiwan

    Sponsors and Collaborators

    • China Medical University Hospital

    Investigators

    • Principal Investigator: Hsien-Yuan Lane, M.D., Ph.D, Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00960219
    Other Study ID Numbers:
    • NSC-97-2314-B-039-006-MY3
    • NSC-97-2314-B-039-006-MY3
    First Posted:
    Aug 17, 2009
    Last Update Posted:
    Jul 11, 2011
    Last Verified:
    Jul 1, 2011
    Additional relevant MeSH terms:
    Disease
    Schizophrenia
    Psychotic Disorders
    Mental Disorders

    Study Results

    No Results Posted as of Jul 11, 2011