A Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Patients With Major Depressive Disorder

Официальное название

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Adult Patients With Major Depressive Disorder

Обзор

A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial, aim to evaluate the efficacy and safety of dextromethorphan and bupropion sustained-release tablets in Chinese adult patients with major depressive disorder.

Вмешательства

• Препарат Dextromethorphan and Bupropion Sustained-Release Tablets
  Oral dextromethorphan and bupropion sustained-release tablets, taken daily for 6 weeks.
• Препарат Placebo
  Oral placebo tablets, taken daily for 6 weeks.

Первичные конечные точки

• Change in MADRS Total Score From Baseline to Week 6 [Срок оценки: 6 weeks]

Вторичные конечные точки (12)

• Treatment response rate (the proportion of participants whose total score on the Montgomery-Åsberg Depression Rating Scale (MADRS) has improved by ≥ 50% compared to the baseline at the 6th week after administration) [Срок оценки: 2 weeks]
• Clinical cure rate (the proportion of participants with a total score of the Montgomery-Åsberg Depression Rating Scale (MADRS) ≤ 10 at the 2nd week after administration) [Срок оценки: 6 weeks]
• Proportion of participants with a ≥ 30% improvement in total MADRS scores from baseline at week 6 after administration [Срок оценки: 6 weeks]
• PGI-I score at week 6 after administration [Срок оценки: 6 weeks]
• CGI-I score (Week 1, Week 2, Week 3, Week 4, Week 6) [Срок оценки: 1，2，3，4，6 weeks]
• Changes in CGI-S score from baseline to week 6 [Срок оценки: 6 weeks]
• Change in QIDS-SR-16 score from baseline to Week 6 [Срок оценки: 6 weeks]
• Change in SDS score from baseline to Week 6 [Срок оценки: 6 weeks]
• Incidence of adve rse events [Срок оценки: Within 7 weeks]
• Incidence of serious adverse events [Срок оценки: Within 7 weeks]
• Proportion of participants with significant abnormalities in vital signs [Срок оценки: Within 7 weeks]
• Proportion of participants with significant abnormalities in physical examination results [Срок оценки: Within 7 weeks]

Критерии участия

Критерии включения

• Male or female, Age 18 - 65, inclusive
• Currently meets DSM-5 diagnosis of MDD without psychotic features, Current major depressive episode of at least 4 weeks in duration at screening
• Identified as MDD by Mini-international Neuropsychiatric interview (M.I.N.I.)
• MADRS score ≥25 and CGI-S ≥4 at screening and baseline
• The results of physical examination and laboratory tests during the screening period meet the test requirements
• Body Mass Index between 18 and 40 kg/m2, inclusive
• For male subjects, use of an adequate method of birth control by the subject and by female sexual partners

Критерии исключения

• 1\. The researchers determined that it was refractory depression \[defined as in a current depressive episode or a previous depressive episode, After 2 or more antidepressants, a sufficient amount (in the maximum recommendation of the manual), a course of foot therapy (at least even Continued medication for 4-6 weeks) ineffective after treatment\] 2. The MADRS score improved by ≥ 25% at baseline compared with the screening period.

3\. Hospitalization in a psychiatric hospital during a current depressive episode 4. There is a clinically significant risk of suicide or self-harm and harm to others 5. Screening patients tested positive for substance abuse 6. In the investigator's judgment, there are any clinically significant oncology, hematology, or internal diseases that are not suitable for entry into the study Secretory/metabolic, cardiovascular, respiratory, kidney, liver, gastrointestinal, infectious or nervous system fever Or suffer from an unstable or progressive chronic disease 7. hypertension 8. Hypothyroidism or hyperthyroidism, except for the following cases: receiving stable medication with no change in dose for at least 1 month before screening (serum TSH must be > 0.75×LLN（ Lower Limit of Normal ） and < 1.25×ULN（Upper Limit of Normal ）) 9 Bupropion, dextromethorphan, opioids (such as codeine), or any of the study drugs Allergic to other ingredients 10. Presence of a history of intolerance to bupropion or dextromethorphan 11. People living with HIV, or testing positive for HIV during screening 12. Screening period hepatitis virology test positive 13. Liver enzyme test results during the screening period (total bilirubin, aspartate aminotransferase and/or alanine aminotransferase) > 2.0 × ULN 14. According to the investigator's judgment, other conditions are not suitable for participating in this clinical study

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Anding Hospital Affiliated to Capital Medical University — Пекин

Идентификаторы

NCT: NCT06958692 · SYH9052-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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