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Combination of NMDA-enhancing and Anti-inflammatory Treatments for Ultra-resistant Schizophrenia

RecruitingPhase 2Ages 18 Years - 65 YearsAllChina Medical University Hospital
NCT05240976 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Previous study found that some NMDA-enhancing agent was able to augment efficacy of clozapine for clinical symptoms but not cognitive function in the treatment of ultra-resistant schizophrenia. In addition, several drugs with anti-inflammatory properties have been tested in clinical trials for the treatment of schizophrenia. Whether a drug with anti-inflammatory property can strengthen the efficacy of an NMDA-enhancer (NMDAE) in the treatment of ultra-resistant schizophrenia remains unknown.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia * 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: * DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder * 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
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What it tests

  • NMDAE plus AIFA
  • NMDAE plus Placebo Cap
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Where

1 site
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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