NCT05240976

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
10mo left

Started Feb 2022

Longer than P75 for phase_2 schizophrenia

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Feb 2022Mar 2027

First Submitted

Initial submission to the registry

January 24, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

February 23, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

4.9 years

First QC Date

January 24, 2022

Last Update Submit

March 21, 2026

Conditions

Schizophrenia

Keywords

Ultra-resistant schizophreniaNMDAInflammation

Outcome Measures

Primary Outcomes (1)

  • Change of cognitive function

    The measure is the composite from multiple measures. All tests have no unit. For the domain (a. and c.) with more than one test, a composite T score will be calculated by standardizing the average of each T score. Furthermore, a global composite score (for all seven domains) and a neurocognitive composite score (for the first 6 domains) will be also calculated by standardizing the average of the T score of each domain (Lane HY et al, JAMA Psychiatry 2013). Ten tests for assessing 7 cognitive domains: 1. speed of processing (assessed by Category Fluency, Trail Marking A, WAIS-III Digit Symbol-Coding); 2. sustained attention (Continuous Performance Test); 3. working memory: verbal (digit span) and nonverbal (spatial span); 4. verbal learning and memory (WMS-III, word listing); 5. visual learning and memory (WMS-III, visual reproduction); 6. reasoning and problem solving (WISC-III, Maze); 7. social cognition (MSCEIT Version 2)

    Week 0, 12

Secondary Outcomes (9)

  • Change of Positive and Negative Syndrome Scale (PANSS)

    week 0, 2, 4, 6, 9, 12

  • Change of scale for the Assessment of Negative Symptoms (SANS) total score

    week 0, 2, 4, 6, 9, 12

  • Chang of positive subscale of PANSS

    week 0, 2, 4, 6, 9, 12

  • Change of negative subscale of PANSS

    week 0, 2, 4, 6, 9, 12

  • Change of general Psychopathology subscale of PANSS

    week 0, 2, 4, 6, 9, 12

  • +4 more secondary outcomes

Study Arms (2)

NMDAE plus Anti-inflammatory Agent (AIFA)

EXPERIMENTAL

An NMDA enhancer plus a drug with anti-inflammatory property

Drug: NMDAE plus AIFA

NMDAE plus Placebo

PLACEBO COMPARATOR

An NMDA enhancer plus Placebo

Drug: NMDAE plus Placebo Cap

Interventions

NMDAE plus AIFADRUG

Use of an NMDA enhancer plus a drug with anti-inflammatory property for the treatment of ultra-resistant schizophrenia.

NMDAE plus Anti-inflammatory Agent (AIFA)
NMDAE plus Placebo CapDRUG

Use of an NMDA enhancer plus placebo as a comparator

NMDAE plus Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

SchizophreniaInflammation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Hsien-Yuan Lane, M.D., Ph.D

CONTACT

886 4 22052121hylane@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 15, 2022

Study Start

February 23, 2022

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

TW(1)