Monotherapy of an NMDA Enhancer for Schizophrenia

NCT04745143 | Recruiting Phase 2 DMC

• 1 other identifier: CMUH105-REC1-050
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies found that some NMDA-enhancing agent was able to augment antioxidant activity and its adjunctive therapy was better than placebo in reducing clinical symptoms and cognitive deficits and revealed favorable safety in patients with chronic schizophrenia. Of note, a substantial portion of schizophrenia patients refuse or cannot tolerate antipsychotics due to poor response or severe side effects. Therefore, this study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) as a monotherapy for the treatment of schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia; NMDA; Oxidative stress

Outcome Measures

Primary Outcomes (2)

• 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

• 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, 2, 4, 6

Secondary Outcomes (6)

• Positive subscale, Negative subscales, and General Psychopathology subscale of Positive and Negative Syndrome Scale (PANSS)

  week 0, 2, 4, 6

• Clinical Global Impression

  week 0, 2, 4, 6

• Global Assessment of Functioning

  week 0, 2, 4, 6

• Hamilton Rating Scale for Depression

  week 0, 2, 4, 6

• Quality of Life Scale

  week 0, 2, 4, 6

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 schizophrenia

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 DSM-5 (American Psychiatric Association) diagnosis of schizophrenia
• Refuse or are unable to tolerate antipsychotics due to poor response or adverse effects
• PANSS total score ≥ 60
• Free of antipsychotic drugs for at least 1 week
• Agree to participate in the study and provide informed consent

You may not qualify if:

• Current substance abuse or history of substance dependence in the past 3 months
• History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study
• Use of depot antipsychotic in the past 3 months;
• Clinically significant laboratory screening tests
• Pregnancy or lactation
• Inability to follow protocol

Sponsors & Collaborators

• China Medical University Hospital: lead
• National Health Research Institutes, 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: January 14, 2021
• First Posted: February 9, 2021
• Study Start: January 1, 2018
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

TW (1)