NCT04917302

Brief Summary

Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with chronic schizophrenia. In addition, several drugs with anti-inflammatory properties have been tested in clinical trials for the treatment of schizophrenia too. Whether combined treatment of an NMDA-enhancing agent and a drug with anti-inflammatory property can be better than an NMDA-enhancing agent alone deserves study.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
7mo left

Started Oct 2020

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 Progress91%
Oct 2020Dec 2026

Study Start

First participant enrolled

October 13, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

6.1 years

First QC Date

June 2, 2021

Last Update Submit

February 16, 2025

Conditions

Schizophrenia

Keywords

SchizophreniaNMDAInflammation

Outcome Measures

Primary Outcomes (1)

  • Change of Positive and Negative Syndrome Scale (PANSS)

    Assessment of overall symptoms. Minimum value: 30, maximum value:210, the higher scores mean a worse outcome.

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

Secondary Outcomes (7)

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

    0, 2, 4, 6, 9, 12

  • Positive subscale, Negative subscales, and General Psychopathology subscale of PANSS

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

  • Clinical Global Impression

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

  • Global Assessment of Functioning

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

  • Hamilton Rating Scale for Depression

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

  • +2 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 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 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

You may not qualify if:

  • DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder
  • 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

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

June 2, 2021

First Posted

June 8, 2021

Study Start

October 13, 2020

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 19, 2025

Record last verified: 2025-02

Locations

TW(1)