Monotherapy of an NMDA Enhancer for Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NMDAE, Placebo Cap.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Drug NMDAE
Use of an NMDA enhancer for the treatment of schizophrenia - Drug Placebo Cap
Use of placebo as a comparator
Primary outcome measures
- Change of Positive and Negative Syndrome Scale (PANSS) [Time frame: week 0, 2, 4, 6]
- Change of scales for the Assessment of Negative Symptoms (SANS) total score [Time frame: week 0, 2, 4, 6]
Secondary outcome measures (6)
- Positive subscale, Negative subscales, and General Psychopathology subscale of Positive and Negative Syndrome Scale (PANSS) [Time frame: week 0, 2, 4, 6]
- Clinical Global Impression [Time frame: week 0, 2, 4, 6]
- Global Assessment of Functioning [Time frame: week 0, 2, 4, 6]
- Hamilton Rating Scale for Depression [Time frame: week 0, 2, 4, 6]
- Quality of Life Scale [Time frame: week 0, 2, 4, 6]
- Cognitive function [Time frame: Week 0, 6]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Department of Psychiatry, China Medical University Hospital — Taichung
Identifiers
NCT: NCT04745143 · CMUH105-REC1-050