NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia

NCT06021197 | Recruiting Phase 2

• 1 other identifier: CMUH111-REC3-228
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive impairment, the core psychopathology of schizophrenia, usually persists in schizophrenia patients even during symptomatic remission. While cognitive impairment associated with schizophrenia (CIAS) is an important therapeutic target, hypofunction of N-methyl-D-aspartate receptor (NMDAR) is a key factor of CIAS. This study aims to examine the efficacy and safety of an NMDA-enhancer (NMDAE) for the treatment of CIAS in schizophrenia patients during symptomatic remission.

Conditions

Schizophrenia

Keywords

Schizophrenia; NMDA; Symptomatic remission

Outcome Measures

Primary Outcomes (1)

• Change of cognitive function composite

  Ten tests for assessment of 7 cognitive domains: 1. speed of processing (assessed by Category Fluency, Trail Marking A, Wechsler Adult Intelligence Scale(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) 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 (Lane HY et al, JAMA Psychiatry 2013)

  Week 0, 12

Secondary Outcomes (2)

• Change of Global Assessment of Functioning composite

  week 0, 4, 8, 12

• Change of Quality of Life Scale

  week 0, 4, 8, 12

Other Outcomes (7)

• Change of Positive and Negative Syndrome Scale (PANSS)

  week 0, 4, 8, 12

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

  week 0, 4, 8, 12

• Change of Positive subscale of PANSS

  week 0, 4, 8, 12

Study Arms (2)

NMDAE

EXPERIMENTAL

An NMDA enhancer

Drug: NMDAE

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo Cap

Interventions

NMDAE DRUG

Use of an NMDA enhancer for the treatment of CIAS

NMDAE

Placebo Cap DRUG

Use of placebo as a comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5 -TR) diagnosis of schizophrenia
• Fulfill the Remission in Schizophrenia Working Group (RSWG) criteria for remission (Andreasen et al., 2005): each of eight items (delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, passive/apathetic social withdrawal, and lack of spontaneity and flow of conversation) in the Positive and Negative Syndrome Scale (PANSS) (Kay et al., 1987) scoring 3 or lower for 6 months or longer; in addition, have a baseline total score of 59 or lower in the PANSS
• Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant;
• Have been keeping a fixed dose of antipsychotics (excluding clozapine) 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-TR 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
• Pregnancy or lactation
• Inability to follow protocol

Sponsors & Collaborators

• China Medical University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

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 Disorders; Mental Disorders

Central Study Contacts

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

CONTACT

886 4 22052121; hylane@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 28, 2023
• First Posted: September 1, 2023
• Study Start: October 12, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

TW (1)