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Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Dedicated Clinical Research
Phoenix, Arizona, 85020 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+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female outpatients aged 18 years or older who are fluent in written and spoken
English.

- A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical
Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode,
without psychotic features.

- A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no
more than a 4-point improvement from screening to baseline.

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

- Significant risk of suicide based on clinical judgment.

- Current (within 12 months before baseline) psychoactive substance abuse or dependence
(including alcohol), manic episode, posttraumatic stress disorder, obsessive
compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.

- Current generalized anxiety disorder, panic disorder, or social anxiety disorder.

- History or current evidence of gastrointestinal disease known to interfere with the
absorption or excretion of drugs or a history of surgery known to interfere with the
absorption or excretion of drugs.

- Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or
other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results.

NCT01432457
Pfizer
Completed
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)

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Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)
A Phase IV, Multicenter, Randomized, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy of 2 Fixed Doses (50 and 100 mg/Day) of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder
A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with major depressive disorder.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: desvenlafaxine succinate sustained-release 50 mg/day
    50 mg tablets of DVS SR taken orally once daily for 8 weeks; 1 week of placebo taper
    Other Name: Pristiq
  • Drug: desvenlafaxine succinate sustained-release 100 mg/day
    100 mg tablets of DVS SR taken orally once daily for 8 weeks (which includes 1 week of titration at 50 mg/day); 1 week of taper at 50 mg/day
  • Drug: placebo
    50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper
  • Experimental: desvenlafaxine succinate sustained-release 50 mg/day
    Intervention: Drug: desvenlafaxine succinate sustained-release 50 mg/day
  • Experimental: desvenlafaxine succinate sustained-release 100 mg/day
    Intervention: Drug: desvenlafaxine succinate sustained-release 100 mg/day
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
924
August 2012
July 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female outpatients aged 18 years or older who are fluent in written and spoken English.
  • A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
  • A HAM-D17 total score ?20 at the screening and baseline (study day -1) visits and no more than a 4-point improvement from screening to baseline.

Exclusion Criteria:

  • Significant risk of suicide based on clinical judgment.
  • Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
  • Current generalized anxiety disorder, panic disorder, or social anxiety disorder.
  • History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
  • Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01432457
B2061028
3151A1-4420
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

ICMJE     Data element required by the

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

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