Actively Recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Adult Patients With Major Depressive Disorder
Led by CSPC Ouyi Pharmaceutical Co., Ltd. · Updated on 2025-05-06
388
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of dextromethorphan and bupropion sustained-release tablets in adult patients with major depressive disorder (MDD). This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness and safety of these tablets in Chinese adults diagnosed with MDD, a condition characterized by a major depressive episode lasting at least 4 weeks. The study is sponsored by CSPC Ouyi Pharmaceutical Co., Ltd. Participants will be randomly assigned to receive either oral dextromethorphan and bupropion sustained-release tablets or a placebo, taken daily for 6 weeks. The study includes careful monitoring and assessments during this treatment period. The primary outcome measured is the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6. Secondary outcomes include treatment response rates, clinical cure rates, various depression and functioning scores, and safety outcomes such as adverse events and laboratory test abnormalities. During the study, participants will undergo evaluations including physical exams, laboratory tests, and psychiatric scales at different time points up to 7 weeks. Safety will be monitored through reports of adverse events, vital signs, ECGs, and suicidal ideation assessments using the Columbia Suicide Severity Rating Scale (C-SSRS). Participants' response to treatment and withdrawal symptoms will also be tracked. Overall, the study duration for each participant is about 6 to 7 weeks, with follow-up assessments to evaluate treatment effects and safety.
CONDITIONS
Brief Title
A Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Patients With Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age 18 to 65 inclusive
- Diagnosed with major depressive disorder without psychotic features according to DSM-5
- Current major depressive episode lasting at least 4 weeks at screening
- Identified as MDD by Mini-international Neuropsychiatric Interview (M.I.N.I.)
- Montgomery-Åsberg Depression Rating Scale (MADRS) score of 25 or higher and Clinical Global Impression-Severity (CGI-S) score of 4 or higher at screening and baseline
- Physical examination and laboratory test results meet study requirements
- Body Mass Index between 18 and 40 kg/m2 inclusive
- Male participants must use effective birth control and ensure female partners do as well
You will not qualify if you...
- Refractory depression defined as inadequate response to two or more antidepressants during current or previous depressive episodes
- Improvement of 25% or more in MADRS score at baseline compared to screening
- Hospitalization in a psychiatric hospital during the current depressive episode
- Clinically significant risk of suicide, self-harm, or harm to others
- Positive test for substance abuse during screening
- Clinically significant oncology, hematology, or internal diseases unsuitable for study participation
- Unstable or progressive chronic diseases including cardiovascular, respiratory, kidney, liver, gastrointestinal, infectious, or nervous system disorders
- Hypertension
- Untreated or unstable hypothyroidism or hyperthyroidism (except stable medication with normal thyroid hormone levels)
- Allergy or intolerance to bupropion, dextromethorphan, opioids, or any study drug ingredients
- HIV positive or living with HIV
- Positive hepatitis virology test during screening
- Elevated liver enzymes exceeding twice the upper limit of normal
- Any other condition judged by the investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants take oral dextromethorphan and bupropion sustained-release tablets or placebo daily to treat major depressive disorder.
Weekly visits for up to 6 weeks
Duration - 1 week
Participants are monitored for safety and any adverse events following treatment completion.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Beijing Anding Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100088
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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