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DAAOI-1 Treatment for Treatment-resistant Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by China Medical University Hospital
Sponsor:
Collaborator:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by (Responsible Party):
Hsien-Yuan Lane, China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01390376
First received: July 7, 2011
Last updated: July 31, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 China Medical University Hospital:

Primary Outcome Measures:
  • The severity of psychiatric symptoms [ Time Frame: week 0, 2, 4, 6 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    score changes

  • Hamilton Depression Rating Scale (HAMD) [ Time Frame: Week 0,2,4, 6 ] [ Designated as safety issue: No ]
  • Cognitive function [ Time Frame: week 0, 6 ] [ Designated as safety issue: No ]
    7 domains of Measurement and Treatment Research to Improve Cognition in Schizophrenia" [MATRICS]


Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fulfilled the DSM-IV criteria of schizophrenia
  • Poor responder of clozapine: a 12-week treatment at adequate plasma concentration 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390376

Contacts
Contact: Hsien-Yuan Lane, M.D., Ph.D 886 921 067260 hylane@gmail.com

Locations
Taiwan
Department of Psychiatry, China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Hsien-Yuan Lane, M.D., Ph.D    886 921 067260    hylane@gmail.com   
Principal Investigator: Hsien-Yuan Lane, M.D., Ph.D         
Sponsors and Collaborators
China Medical University Hospital
Department of Health, Executive Yuan, R.O.C. (Taiwan)
  More Information

No publications provided

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
Study First Received: July 7, 2011
Last Updated: July 31, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
Schizophrenia
NMDA
DAAOI
Clozapine resistant schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 25, 2014