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.
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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

Clinical Trials Information Group officer

86-0311-69085587

ctr-contact@cspc.cn

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