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DAAOI-1 Treatment for Treatment-resistant Schizophrenia

This study is currently recruiting participants.
Verified April 2012 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: April 9, 2012
Last verified: April 2012
History of Changes
  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:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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 ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (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 55 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
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: April 9, 2012
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013