You are here

Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Birmingham Research Group Inc.
Birmingham, Alabama, 35216 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT01309542
Pfizer
Completed
Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Major Depressive Disorder
NCT02548949
All Genders
19+
Years
Multiple Sites
Post-Traumatic Stress Disorders
NCT00150306
All Genders
6+
Years
Multiple Sites
Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder
A 10 Month Open-Label Evaluation Of The Long-Term Safety Of DVS-233 SR In Outpatients With Major Depressive Disorder.
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).
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Major Depressive Disorder
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
Experimental: DVS
Intervention: Drug: Desvenlafaxine Succinate
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.
 
Completed
1403
March 2006
March 2006   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Estonia,   Finland,   Former Serbia and Montenegro,   France,   Germany,   Latvia,   Lithuania,   Poland,   Slovakia,   South Africa,   United States
 
 
NCT01309542
3151A1-303
B2061069
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now