Combination of NMDA-enhancing and Anti-inflammatory Treatments for Ultra-resistant Schizophrenia
NCT ID: NCT05240976
Last Updated: 2024-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2022-02-23
2027-03-31
Brief Summary
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Detailed Description
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Therefore, this study aims to compare NMDAE plus a drug with anti-inflammatory property and NMDAE plus placebo in the treatment of ultra-resistant schizophrenia. The subjects are the patients with ultra-resistant schizophrenia who have responded poorly to clozapine treatment. They keep their original clozapine treatment and are randomly, double-blindly assigned into two treatment groups for 12 weeks: (1) NMDAE plus Anti-inflammatory Agent (AIFA), or (2) NMDAE plus placebo. Cognitive functions are assessed at baseline and at endpoint of treatment by a battery of tests. Clinical performances and side effects are measured at weeks 0, 2, 4, 6, 9, and 12. The efficacies of NMDAE plus AIFA and NMDAE plus placebo will be compared.
Chi-square (or Fisher's exact test) will be used to compare differences of categorical variables and t-test (or Mann-Whitney test if the distribution is not normal) for continuous variables between treatment groups. Mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (GEE) for both primary and secondary outcomes . All p values for clinical measures will be based on two-tailed tests with a significance level of 0.05.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NMDAE plus Anti-inflammatory Agent (AIFA)
An NMDA enhancer plus a drug with anti-inflammatory property
NMDAE plus AIFA
Use of an NMDA enhancer plus a drug with anti-inflammatory property for the treatment of ultra-resistant schizophrenia.
NMDAE plus Placebo
An NMDA enhancer plus Placebo
NMDAE plus Placebo Cap
Use of an NMDA enhancer plus placebo as a comparator
Interventions
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NMDAE plus AIFA
Use of an NMDA enhancer plus a drug with anti-inflammatory property for the treatment of ultra-resistant schizophrenia.
NMDAE plus Placebo Cap
Use of an NMDA enhancer plus placebo as a comparator
Eligibility Criteria
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Inclusion Criteria
* Are treatment-resistant to standard treatments of at least two specific antipsychotics before clozapine treatment
* Are receiving adequate trials of clozapine for more than 12 weeks but without satisfactory response
* PANSS total score ≥ 70; SANS total score ≥ 40
* Have sufficient education to communicate effectively and are capable of completing the assessments of the study
* Agree to participate in the study and provide informed consent
Exclusion Criteria
* History of epilepsy, head trauma, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study
* Clinically significant laboratory screening tests (including blood routine, biochemical tests)
* Pregnancy or lactation
* Inability to follow protocol
18 Years
65 Years
ALL
No
Sponsors
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National Health Research Institutes, Taiwan
OTHER
China Medical University Hospital
OTHER
Responsible Party
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Locations
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Department of Psychiatry, China Medical University Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CMUH109-REC3-043
Identifier Type: -
Identifier Source: org_study_id
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