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

Who is this study for? Patients with Schizophrenia
What treatments are being studied? NMDA-Enhancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Taiwan
Department of Psychiatry, China Medical University Hospital
RECRUITING
Taichung
Contact Information
Primary
Hsien-Yuan Lane, M.D., Ph.D
hylane@gmail.com
886 4 22052121
Time Frame
Start Date: 2022-02-23
Estimated Completion Date: 2027-03
Participants
Target number of participants: 80
Treatments
Experimental: NMDAE plus Anti-inflammatory Agent (AIFA)
An NMDA enhancer plus a drug with anti-inflammatory property
Placebo_comparator: NMDAE plus Placebo
An NMDA enhancer plus Placebo
Related Therapeutic Areas
Sponsors
Collaborators: National Health Research Institutes, Taiwan
Leads: China Medical University Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials