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

NCT01432457

Last updated date
Study Location
Dedicated Clinical Research
Phoenix, Arizona, 85020, United States
Contact
1-800-718-1021

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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   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
 (submitted: September 5, 2012)
924
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2011)
900
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01432457
Other Study ID Numbers  ICMJE B2061028
3151A1-4420
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP