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

ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChina Medical University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • NMDAE plus AIFA
  • NMDAE plus Placebo Cap

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

China Medical University Hospital

Lead sponsor

National Health Research Institutes, Taiwan

Collaborator