Combination of NMDA-enhancing and Anti-inflammatory Treatments for Schizophrenia
NCT ID: NCT04917302
Last Updated: 2025-02-19
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
60 participants
INTERVENTIONAL
2020-10-13
2026-12-31
Brief Summary
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Detailed Description
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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). 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 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 schizophrenia.
NMDAE plus Placebo Cap
Use of an NMDA enhancer plus placebo as a comparator
Eligibility Criteria
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Inclusion Criteria
* Are resistant to adequate treatments of at least two antipsychotics
* Remain symptomatic but without clinically significant fluctuation, while their antipsychotic doses are unchanged for at least 3 months and will be maintained during the period of the 12-week trial
* PANSS total score ≥ 70
* Agree to participate in the study and provide informed consent
Exclusion Criteria
* History of epilepsy, head trauma, stroke, 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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Ministry of Science and Technology, Taiwan
OTHER_GOV
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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CMUH108-REC1-178
Identifier Type: -
Identifier Source: org_study_id
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