Combination of NMDA-enhancing and Antioxidant Treatments 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 plus AO, NMDAE plus 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 agents were able to improve clinical symptoms of patients with schizophrenia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of schizophrenia too. Whether combined treatment of an NMDA-enhancing agent and a drug with antioxidant property can be better than an NMDA-enhancing agent alone deserves study.
Detailed description
Several lines of evidence suggest that both NMDA and oxidative stress hypotheses have been implicated in schizophrenia. Previous studies found that some NMDA-enhancing agents were able to augment efficacy of antipsychotics in the treatment of schizophrenia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of schizophrenia too. Whether a drug with antioxidant property can strengthen the efficacy of an NMDA-enhancer (NMDAE) in the treatment of schizophrenia remains unknown. Therefore, this study aims to compare NMDAE plus a drug with antioxidant property and NMDAE plus placebo in the treatment of schizophrenia. The subjects are the schizophrenia patients who remain symptomatic while having been stabilized with antipsychotic treatment. They keep their original treatment and are randomly, double-blindly assigned into two treatment groups for 12 weeks: (1) NMDAE plus Antioxidant agent (AO), or (2) NMDAE plus placebo. Clinical performances and side effects are measured at weeks 0, 2, 4, 6, 9, and 12. Cognitive functions are assessed at baseline and at endpoint of treatment by a battery of tests. The efficacies of NMDAE plus AO and NMDAE plus 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 plus AO
Use of an NMDA enhancer plus a drug with antioxidant property for the treatment of schizophrenia. - Drug NMDAE plus Placebo Cap
Use of an NMDA enhancer plus placebo as a comparator.
Primary outcome measures
- Change of Positive and Negative Syndrome Scale (PANSS) [Time frame: week 0, 2, 4, 6, 9, 12]
Secondary outcome measures (9)
- Change of scales for the Assessment of Negative Symptoms (SANS) total score [Time frame: week 0, 2, 4, 6, 9, 12]
- Positive subscale of PANSS [Time frame: week 0, 2, 4, 6, 9, 12]
- Negative subscale of PANSS [Time frame: week 0, 2, 4, 6, 9, 12]
- General Psychopathology subscale of PANSS [Time frame: week 0, 2, 4, 6, 9, 12]
- Clinical Global Impression [Time frame: week 0, 2, 4, 6, 9, 12]
- Global Assessment of Functioning [Time frame: week 0, 2, 4, 6, 9, 12]
- Hamilton Rating Scale for Depression [Time frame: week 0, 2, 4, 6, 9, 12]
- Quality of Life Scale [Time frame: week 0, 2, 4, 6, 9, 12]
- Cognitive function [Time frame: Week 0, 12]
Eligibility criteria
Inclusion criteria
- Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia
- Remain symptomatic but without clinically significant fluctuation, while their antipsychotic doses are unchanged for at least 3 months and will be maintained during the period of the 12-week trial
- PANSS total score ≥ 60
- Agree to participate in the study and provide informed consent
Exclusion criteria
- DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder
- History of epilepsy, head trauma, stroke, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study
- Clinically significant laboratory screening tests (including blood routine, biochemical 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: NCT04959201 · CMUH108-REC1-177