Actively Recruiting
A Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Patients With Major Depressive Disorder
Led by CSPC Ouyi Pharmaceutical Co., Ltd. · Updated on 2025-05-06
388
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 aged 18 to 65 years, inclusive
- Currently meets DSM-5 diagnosis of major depressive disorder without psychotic features
- Current major depressive episode lasting at least 4 weeks at screening
- Diagnosed with MDD by Mini-international Neuropsychiatric Interview (M.I.N.I.)
- MADRS score of 25 or higher and CGI-S score of 4 or higher at screening and baseline
- Physical exam and lab test results meet study requirements
- Body mass index between 18 and 40 kg/m2, inclusive
- Male participants must use adequate birth control and ensure female partners do as well
You will not qualify if you...
- Refractory depression defined as ineffective treatment after 2 or more antidepressants and sufficient therapy course
- MADRS score improved by 25% or more at baseline compared with screening
- Hospitalization in a psychiatric hospital during current depressive episode
- Clinically significant risk of suicide, self-harm, or harm to others
- Positive test for substance abuse at screening
- Clinically significant oncology, hematology, or internal diseases unsuitable for study entry including unstable or progressive chronic diseases
- Hypertension
- Untreated hypothyroidism or hyperthyroidism unless stable medication with no dose change for at least 1 month before screening and serum TSH within specified limits
- Allergy or intolerance to bupropion, dextromethorphan, opioids, or study drug ingredients
- Living with or testing positive for HIV during screening
- Positive hepatitis virology test during screening
- Liver enzyme tests during screening greater than 2 times the upper limit of normal
- Any other conditions judged by investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here