A Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Patients With Major Depressive Disorder
Recruiting
Phase 3
Interventional Study
Major Depressive Disorder (MDD)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 388 (estimated)
- Sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male or female, Age 18 - 65, inclusive
2. Currently meets DSM-5 diagnosis of MDD without psychotic features, Current major depressive episode of at least 4 weeks in duration at screening
3. Identified as MDD by Mini-international Neuropsychiatric interview (M.I.N.I.)
4. MADRS…
Contacts