A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study Of DVS-233 SR And Venlafaxine ER In Adult Outpatients With Major Depressive Disorder
Data Collection
Mental Disorders+3
+ Behavioral Symptoms
+ Depression
Treatment Study
Summary
To compare the antidepressant efficacy and safety of DVS-233 SR with those of placebo in adult outpatients with MDD.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.369 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Men and women 18 to 75 years of age, inclusive. * Sexually active individuals participating in the study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article * Subjects must have a primary diagnosis of major depressive disorder Exclusion Criteria: * Treatment with DVS-233 SR at any time in the past * Treatment with venlafaxine (immediate release \[IR\] or extended release \[ER\]) within 90 days of study day 1 * Known hypersensitivity to venlafaxine (IR or ER)