Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder
- Registration Number
- NCT01309542
- Lead Sponsor
- Pfizer
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1403
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DVS Desvenlafaxine Succinate -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in Hamilton Depression Rating scale - 17 items version - (HAM-D17) mean score from baseline 10 months 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
Trial Locations
- Locations (115)
Birmingham Research Group Inc.
🇺🇸Birmingham, Alabama, United States
Pivotal Research Centers 13128 North 94th Drive, Suite 200
🇺🇸Mesa, Arizona, United States
Pivotal Research
🇺🇸Peoria, Arizona, United States
Southwestern Research, Inc.
🇺🇸Tustin, California, United States
Feighner Research Institute
🇺🇸Chula Vista, California, United States
California Clinical Trials Medical Group, Inc.
🇺🇸Glendale, California, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Pacific Clinical Research
🇺🇸Orange, California, United States
UCSD Department of Psychiatry Psychopharmacology Research
🇺🇸San Diego, California, United States
Alpine Clinical Research Center, Inc.
🇺🇸Boulder, Colorado, United States
Scroll for more (105 remaining)Birmingham Research Group Inc.🇺🇸Birmingham, Alabama, United States