Major Depressive Disorder
Conditions
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients who have completed double-blind therapy in a phase 3 DVS-233 SR short-term study for the indication of MDD, including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject’s entry into the long-term, open-label study. 2. Signed and dated informed consent before any study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Clinically important abnormalities on baseline (day 56 of the short-term studies) physical examination, or any unresolved clinically significant abnormalities on ECG, laboratory test results, or vital signs recorded before day 56 in a previous phase 3 DVS-233 SR short-term study for the indication of MDD. If an exception for any underlying illness was granted for entry in the short-term study and if the condition remains stable (ie, no exacerbation), then the subject may enter the long-term study. Any exception must be discussed with and granted by the sponsor. 2. Significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention. 3. Presence of clinically important hepatic or renal disease or other medical disease that might compromise the study or be detrimental to the subject (eg, clinically important cardiac arrhythmia, uncontrolled diabetes, uncontrolled hypertension, seizure disorder, myocardial infarction, neurological disorder, acute illness, neoplastic disorder). 4. Known presence of raised intraocular pressure or history of narrow-angle glaucoma. 5. Use of prohibited treatments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to evaluate the long-term safety of DVS-233 SR during open-label treatment of outpatients with Major Depressive Disorder (MDD).;Secondary Objective: The secondary objective will be to evaluate the long-term response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general well-being, pain, and absence of symptoms.;Primary end point(s): The primary objective of this study is to assess the safety and tolerability of long-term therapy with DVS-233 SR tablets. | — |
Countries
Latvia, Lithuania
Outcome results
None listed