Major Depressive Disorder
Conditions
Keywords
major depressive disorder, desvenlafaxine, antidepressant
Brief summary
The study evaluated the long-term safety of Desvenlafaxine Succinate (DVS) Slow Release (SR) during open-label treatment in adult outpatients who had a primary diagnosis of major depressive disorder (MDD). The study also evaluated the long-term response of subjects receiving DVS SR for clinical global evaluation, functionality, general well-being, pain, and absence of depressive symptoms (remission).
Interventions
Tablet were taken at a daily dose of 200 to 400 mg/day for a duration up to 10 months
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Sexually active individuals participating in the study must use a medically acceptable form of contraception during the trial and for at least 15 days after the last dose of study drug.
Exclusion criteria
* Clinically important abnormalities on baseline physical examination, or any unresolved clinically significant abnormalities on ECG, laboratory test results, or vital signs recorded in a previous phase 3 DVS-233 SR short-term study for the indication of MDD. Any exception must be discussed with and granted by the sponsor. * 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. * 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, neurologic disorder, acute illness, neoplastic disorder).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number (%) of Subjects Reporting Adverse Events during Treatment | 10 months |
| Number (%) of Subjects With Changes in Vital Signs (Blood Pressure, Pulse Rate, Weight) of Potential Clinical Importance | 10 months |
| Number (%) of Subjects With Laboratory Test Results (Hematology, Blood Chemistry, Lipid Profile, Urinalysis) of Potential Clinical Importance | 10 months |
| Number (%) of Subjects With Electrocardiogram Results (Heart Rate, QTc interval) of Potential Clinical Importance | 10 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in Montgomery Asberg Depression Rating Scale (MADRS)mean score from baseline | 10 months |
| Change in Clinical Global Improvement Scale-Severity (CGI-S)mean score from baseline | 10 months |
| Change in Hamilton Depression Rating scale - 17 items version - (HAM-D17) mean score from baseline | 10 months |
Countries
Estonia, Finland, France, Germany, Latvia, Lithuania, Poland, Serbia and Montenegro, Slovakia, South Africa, United States
Outcome results
None listed