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DAAOI-1 Treatment for Treatment-resistant Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01390376
First Posted: July 11, 2011
Last Update Posted: March 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by (Responsible Party):
Hsien-Yuan Lane, China Medical University Hospital
  Purpose

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.


Condition Intervention Phase
Schizophrenia Drug: DAAOI-1 Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: DAAOI-1 Treatment for Treatment-resistant Schizophrenia

Resource links provided by NLM:


Further study details as provided by Hsien-Yuan Lane, China Medical University Hospital:

Primary Outcome Measures:
  • The severity of psychiatric symptoms [ Time Frame: week 0, 2, 4, 6 ]

    The severity of psychiatric symptoms will be assessed by:

    1. Positive and Negative Syndrome Scale(PANSS)
    2. Assessment of Negative symptoms(SANS)
    3. Global assessment of function(GAF)
    4. Quality of life scale(QOL)


Secondary Outcome Measures:
  • PANSS subscales [ Time Frame: week 0,2,4,6 ]
    score changes

  • Hamilton Depression Rating Scale (HAMD) [ Time Frame: Week 0,2,4, 6 ]
  • Cognitive function [ Time Frame: week 0, 6 ]
    7 domains of Measurement and Treatment Research to Improve Cognition in Schizophrenia" [MATRICS]


Enrollment: 60
Study Start Date: September 2010
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BE 1
DAAOI-1 1g
Drug: DAAOI-1
DAAOI-1 1g
Experimental: BE 2
DAAOI-1 2g
Drug: DAAOI-1
DAAOI-1 2g
Placebo Comparator: starch pill Drug: placebo
starch pill

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390376


Locations
Taiwan
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan
Sponsors and Collaborators
China Medical University Hospital
Department of Health, Executive Yuan, R.O.C. (Taiwan)
  More Information

Responsible Party: Hsien-Yuan Lane, Departement of psychiatry, China Medical University Hospital, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01390376     History of Changes
Other Study ID Numbers: DOH99-TD-I-111-TM001
First Submitted: July 7, 2011
First Posted: July 11, 2011
Last Update Posted: March 31, 2016
Last Verified: March 2016

Keywords provided by Hsien-Yuan Lane, China Medical University Hospital:
Schizophrenia
NMDA
DAAOI
Clozapine resistant schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders