A Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Patients With Major Depressive Disorder
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: Dextromethorphan and Bupropion Sustained-Release Tablets, Placebo.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder (MDD). 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
- China
- 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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Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Adult Patients With Major Depressive Disorder
Overview
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.
Interventions
- Drug Dextromethorphan and Bupropion Sustained-Release Tablets
Oral dextromethorphan and bupropion sustained-release tablets, taken daily for 6 weeks. - Drug Placebo
Oral placebo tablets, taken daily for 6 weeks.
Primary outcome measures
- Change in MADRS Total Score From Baseline to Week 6 [Time frame: 6 weeks]
Secondary outcome measures (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) [Time frame: 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) [Time frame: 6 weeks]
- Proportion of participants with a ≥ 30% improvement in total MADRS scores from baseline at week 6 after administration [Time frame: 6 weeks]
- PGI-I score at week 6 after administration [Time frame: 6 weeks]
- CGI-I score (Week 1, Week 2, Week 3, Week 4, Week 6) [Time frame: 1，2，3，4，6 weeks]
- Changes in CGI-S score from baseline to week 6 [Time frame: 6 weeks]
- Change in QIDS-SR-16 score from baseline to Week 6 [Time frame: 6 weeks]
- Change in SDS score from baseline to Week 6 [Time frame: 6 weeks]
- Incidence of adve rse events [Time frame: Within 7 weeks]
- Incidence of serious adverse events [Time frame: Within 7 weeks]
- Proportion of participants with significant abnormalities in vital signs [Time frame: Within 7 weeks]
- Proportion of participants with significant abnormalities in physical examination results [Time frame: Within 7 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
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
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Anding Hospital Affiliated to Capital Medical University — Beijing
Identifiers
NCT: NCT06958692 · SYH9052-002