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Monotherapy of an NMDA Enhancer for Schizophrenia

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ClinicalTrials.gov Identifier: NCT04745143
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : March 11, 2022
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
China Medical University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: NMDAE Drug: Placebo Cap Phase 2

Detailed Description:

Several lines of evidence suggest that schizophrenia is associated with accelerated aging and oxidative stress may play a role. Cognitive deficits are core symptoms of accelerated aging in patients with schizophrenia and the most difficult domain to treat. Current antipsychotics have limited, if any, efficacy for cognitive function. Previous studies found that some NMDA-enhancing agent was able to augment antioxidant activity and its adjunctive therapy was better than placebo in reducing not only clinical symptoms but also 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. This study aims to examine the efficacy and safety of NMDAE monotherapy for the treatment of schizophrenia. The investigators enroll patients with schizophrenia who refuse or are unable to tolerate antipsychotics due to poor response or adverse effects into a 6-week randomized, double-blind trial to receive monotherapy of NMDAE or placebo. The investigators biweekly measure clinical performances and side effects. Cognitive functions are assessed at baseline and at endpoint of treatment by a battery of tests. The efficacies of NMDAE and placebo will be compared.

Chi-square (or Fisher's exact test) will be used to compare differences of categorical variables and t-test (or Mann-Whitney test if the distribution is not normal) for continuous variables between treatment groups. Mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (GEE). All p values for clinical measures will be based on two-tailed tests with a significance level of 0.05.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Monotherapy of an NMDA Enhancer for Schizophrenia
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: NMDAE
An NMDA enhancer
 Drug: NMDAE
Use of an NMDA enhancer for the treatment of schizophrenia
Placebo Comparator: Placebo
Placebo
 Drug: Placebo Cap
Use of placebo as a comparator


Outcome Measures
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Primary Outcome Measures :
  1. Change of Positive and Negative Syndrome Scale (PANSS) [ Time Frame: week 0, 2, 4, 6 ]
    Assessment of overall symptoms. Minimum value: 30, maximum value:210, the higher scores mean a worse outcome.

  2. Change of scales for the Assessment of Negative Symptoms (SANS) total score [ Time Frame: week 0, 2, 4, 6 ]
    Assessment of negative symptoms. Minimum value: 0, maximum value:100, the higher scores mean a worse outcome.


Secondary Outcome Measures :
  1. Positive subscale, Negative subscales, and General Psychopathology subscale of Positive and Negative Syndrome Scale (PANSS) [ Time Frame: week 0, 2, 4, 6 ]

    PANSS-positive: Assessment of positive symptoms. Minimum value: 7, maximum value:49, the higher scores mean a worse outcome.

    PANSS-negative: Assessment of negative symptoms. Minimum value: 7, maximum value:49, the higher scores mean a worse outcome.

    PANSS-general psychopathology: Assessment of general psychopathology. Minimum value: 16, maximum value:112, the higher scores mean a worse outcome.


  2. Clinical Global Impression [ Time Frame: week 0, 2, 4, 6 ]
    Assessment of general impression. Minimum value: 1, maximum value:7, the higher scores mean a worse outcome.

  3. Global Assessment of Functioning [ Time Frame: week 0, 2, 4, 6 ]
    Assessment of social, occupational, and psychological function. Minimum value: 1, maximum value:100, the higher scores mean better function.

  4. Hamilton Rating Scale for Depression [ Time Frame: week 0, 2, 4, 6 ]
    Assessment of depressive symptoms. Minimum value: 0, maximum value:52, the higher scores mean a worse outcome.

  5. Quality of Life Scale [ Time Frame: week 0, 2, 4, 6 ]
    Assessment of life quality. Minimum value: 0, maximum value:126, the higher scores mean a better outcome.

  6. Cognitive function [ Time Frame: Week 0, 6 ]

    The measure is the composite from multiple measures.

    Ten cognitive tests for assessment of 7 cognitive domains:

    1. speed of processing (assessed by 3 tests: 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 (the Mayer-Salovey-Caruso Emotional Intelligence Test [MSCEIT] Version 2)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04745143


Contacts
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Contact: Hsien-Yuan Lane, M.D., Ph.D 886 4 22052121 ext 1855 hylane@gmail.com

Locations
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Taiwan
Department of Psychiatry, China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Hsien-Yuan Lane, M.D., Ph.D    886 4 22052121 ext 1855    hylane@gmail.com   
Sponsors and Collaborators
China Medical University Hospital
National Health Research Institutes, Taiwan
More Information
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04745143    
Other Study ID Numbers: CMUH105-REC1-050
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China Medical University Hospital:
Schizophrenia
NMDA
Oxidative stress
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders