NCT07122895

Brief Summary

Schizophrenia differs between sexes in clinical symptoms and functional outcome. Negative symptoms are the core pathology of this disease. NMDA receptor (NMDAR) dysfunction is a key factor in negative symptoms. This study aims to examine the sex difference in the efficacy of an NMDA-enhancer (NMDAE) for the treatment of negative symptoms in schizophrenia.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
46mo left

Started Sep 2025

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

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Study Timeline

Key milestones and dates

Study Progress14%
Sep 2025Mar 2030

First Submitted

Initial submission to the registry

August 8, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 16, 2025

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

4.2 years

First QC Date

August 8, 2025

Last Update Submit

September 16, 2025

Conditions

Schizophrenia

Keywords

SchizophreniaNMDANegative symptomsSex difference

Outcome Measures

Primary Outcomes (1)

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

    Assessment of negative symptoms. Minimum value: 0, maximum value:100, the higher scores mean a worse outcome.

    week 0, 4, 8, 12

Secondary Outcomes (5)

  • Change of Negative subscale of PANSS

    week 0, 4, 8, 12

  • Change of Clinical Global Impression

    Frame: week 0, 4, 8, 12

  • Change of Global Assessment of Functioning composite

    week 0, 4, 8, 12

  • Change of Quality of Life Scale

    week 0, 4, 8, 12

  • Change of cognitive function composite

    Week 0, 12

Other Outcomes (4)

  • Change of Positive and Negative Syndrome Scale (PANSS)

    week 0, 4, 8, 12

  • Change of Positive subscale of PANSS

    Frame: week 0, 4, 8, 12

  • Change of General Psychopathology subscale of PANSS

    week 0, 4, 8, 12

  • +1 more other outcomes

Study Arms (2)

NMDAE

EXPERIMENTAL

An NMDA enhancer

Drug: NMDAE

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo Cap

Interventions

NMDAEDRUG

Use of an NMDA enhancer for the treatment of negative symptoms

NMDAE
Placebo CapDRUG

Use of placebo as a comparator

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia
  • keep stable mentally for ≥ 6 months before baseline and meet the following clinical criteria: predominantly negative symptoms for ≥ 6 months, a minimum baseline total score of 40 on the SANS, a minimum baseline score of 24 on the negative subscale of the PANSS, and a maximum score of 3 on each item of PANSS-positive subscale;
  • Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant;
  • Have been keeping a fixed dose of antipsychotics for at least 6 months, and that is not allowed to change during the 12-week study period
  • Have sufficient education to communicate effectively and are capable of completing the assessments of the study
  • Agree to participate in the study and provide written 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 evident depressive symptoms or a baseline score\>7 on the Hamilton Depression Rating Scale-17 items
  • Clinically relevant parkinsonism or a baseline score \>3 on the sum of the first eight items of the Simpson-Angus Scale (SAS)
  • 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

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

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

August 8, 2025

First Posted

August 14, 2025

Study Start

September 16, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

March 1, 2030

Last Updated

September 17, 2025

Record last verified: 2025-09

Locations

TW(1)