Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder
NCT01309542
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- 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).
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Descriptive Information | ||||
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Brief Title ICMJE | Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder | |||
Official Title ICMJE | A 10 Month Open-Label Evaluation Of The Long-Term Safety Of DVS-233 SR In Outpatients With Major Depressive Disorder. | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Major Depressive Disorder | |||
Intervention ICMJE | Drug: Desvenlafaxine Succinate
Tablet were taken at a daily dose of 200 to 400 mg/day for a duration up to 10 months Other Name: DVS-233 SR | |||
Study Arms ICMJE | Experimental: DVS
Intervention: Drug: Desvenlafaxine Succinate | |||
Publications * | Tourian KA, Pitrosky B, Padmanabhan SK, Rosas GR. A 10-month, open-label evaluation of desvenlafaxine in outpatients with major depressive disorder. Prim Care Companion CNS Disord. 2011;13(2). pii: PCC.10m00977. doi: 10.4088/PCC.10m00977blu. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 1403 | |||
Original Actual Enrollment ICMJE | 1408 | |||
Actual Study Completion Date ICMJE | March 2006 | |||
Actual Primary Completion Date | March 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Estonia, Finland, Former Serbia and Montenegro, France, Germany, Latvia, Lithuania, Poland, Slovakia, South Africa, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01309542 | |||
Other Study ID Numbers ICMJE | 3151A1-303 B2061069 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | April 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |