Dual Modulation of Sigma-1 and NMDA Receptors in the Treatment of Schizophrenia
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: S1RA plus NMDAE, S1RA plus Placebo Cap.
- Кому может быть актуально
- Состояния в реестре: Schizophrenia. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
sigma-1 receptor (S1R) agonistic property have been tested in clinical trials for the treatment of schizophrenia. In addition, previous studies found that some NMDA receptor (NMDAR)-enhancing agents were able to improve clinical symptoms of patients with chronic schizophrenia. Whether combined treatment of an S1R agonist and an NMDA-enhancing agent can be better than an S1R agonist alone deserves study.
Подробное описание
The current treatment for schizophrenia remains unsatisfactory; thus, development of new treatments is vital. Both sigma-1 receptor (S1R) dysfunction and NMDA receptor (NMDAR) hypofunction contribute to pathogenesis of schizophrenia, especially treatment-resistant schizophrenia. Several S1R agonists have been tested for its potential for schizophrenia treatment; however, its efficacy appears limited. In addition, previous studies also found that some NMDA-enhancing agents were able to augment efficacy of antipsychotics in the treatment of chronic schizophrenia. Whether combined treatment of an S1R agonist and an NMDA-enhancer (NMDAE) can be better than an S1R agonist alone deserves study. Therefore, this study aims to compare an S1R agonist plus an NMDAE and an S1R agonist plus placebo in the treatment of treatment-resistant schizophrenia. The subjects are the patients with treatment-resistant schizophrenia who have responded poorly to two or more kinds of antipsychotics treatment. They keep their original treatment and are randomly, double-blindly assigned into two treatment groups for 12 weeks: (1) S1R agonist (S1RA) plus NMDAE, or (2) S1RA plus placebo. Clinical performances and side effects are measured at weeks 0, 2, 4, 6, and 8. Cognitive functions are assessed at baseline and at endpoint of treatment by a battery of tests. The efficacies of S1RA plus NMDAE and S1RA 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.
Вмешательства
- Препарат S1RA plus NMDAE
Use of an S1R agonist plus an NMDA enhancer for the treatment of treatment-resistant schizophrenia. - Препарат S1RA plus Placebo Cap
Use of an S1R agonist plus placebo as a comparator
Первичные конечные точки
- Change of Positive and Negative Syndrome Scale (PANSS) [Срок оценки: week 0, 2, 4, 6, 8]
Вторичные конечные точки (6)
- Change of scales for the Assessment of Negative Symptoms (SANS) total score [Срок оценки: week 0, 2, 4, 6, 8]
- Positive subscale, Negative subscales, and General Psychopathology subscale of PANSS [Срок оценки: week 0, 2, 4, 6, 8]
- Clinical Global Impression [Срок оценки: week 0, 2, 4, 6, 8]
- Global Assessment of Functioning [Срок оценки: week 0, 2, 4, 6, 8]
- Quality of Life Scale [Срок оценки: week 0, 2, 4, 6, 8]
- Cognitive function [Срок оценки: Week 0, 8]
Критерии участия
Критерии включения
- Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia
- Are resistant to adequate treatments of at least two antipsychotics (excluding clozapine)
- 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 8-week trial
- PANSS total score >70
- Hamilton Depression Rating Scale-17 items (HAMD) <7
- Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant.
- Have sufficient education to communicate effectively and are capable of completing the assessments of the study.
- Agree to participate in the study and provide informed consent
Критерии исключения
- DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder
- History of epilepsy, head trauma, central nervous system diseases or mental disorders other than schizophrenia (including major depressive disorder, bipolar disorders, persistent depressive disorder, obsessive-compulsive disorder)
- Pregnancy or lactation
- Inability to follow protocol
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Тайвань · 1 центр
- Department of Psychiatry, China Medical University Hospital — Taichung
Идентификаторы
NCT: NCT06574360 · CMUH112-REC3-202