DAAOI-1 Treatment for Treatment-resistant Schizophrenia
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 schizophrenia
Started Sep 2010
Longer than P75 for phase_2 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 7, 2011
CompletedFirst Posted
Study publicly available on registry
July 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedMarch 31, 2016
March 1, 2016
4 years
July 7, 2011
March 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The severity of psychiatric symptoms
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)
week 0, 2, 4, 6
Secondary Outcomes (3)
PANSS subscales
week 0,2,4,6
Hamilton Depression Rating Scale (HAMD)
Week 0,2,4, 6
Cognitive function
week 0, 6
Study Arms (3)
BE 1
EXPERIMENTALDAAOI-1 1g
BE 2
EXPERIMENTALDAAOI-1 2g
starch pill
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Departement of psychiatry, China Medical University Hospital
Study Record Dates
First Submitted
July 7, 2011
First Posted
July 11, 2011
Study Start
September 1, 2010
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
March 31, 2016
Record last verified: 2016-03