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New treatment option for Major Depressive Disorder (MDD)
Official title A Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT06958692
What this study is testing
What is Dextromethorphan and Bupropion Sustained-Release Tablets?
Dextromethorphan and Bupropion Sustained-Release Tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for major depressive disorder (mdd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 1\. The researchers determined that it was refractory depression [defined as in a current depressive episode or a previous depressive episode, After...
- 3\. Hospitalization in a psychiatric hospital during a current depressive episode 4. There is a clinically significant risk of suicide or self-harm...
See the full eligibility 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 people, use of an adequate method of birth control by the subject and by female sexual partners
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.