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Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Beverly Hills, California, 90210 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

- Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive
symptoms for at least 30 days prior to screening)

- Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20

- Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4.

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

- Significant risk of suicide as assessed by clinician judgment, HAM-D17 and Columbia
Suicide-Severity Rating Scale scores.

- Past treatment with desvenlafaxine succinate sustained release.

- Other eligibility criteria also apply.

NCT00887224
Pfizer
Completed
Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

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Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder
A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study To Evaluate The Efficacy And Safety Of 50 mg/Day Of DVS SR In Adult Outpatients With Major Depressive Disorder

The primary purpose of this study is to compare the long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive Disorder, using a randomized withdrawal design. Randomized withdrawal means that after receiving desvenlafaxine succinate sustained release for a predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial. Subjects will not know to which group they have been assigned.

The study consists of an up to 14-day screening period followed by an 8-week open-label period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate sustained release. Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine succinate sustained release at the same dose. Subjects with stable response to treatment at the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or until symptoms of depression return. Following discontinuation at any point after enrollment in the study, subjects will receive two weeks of follow-up monitoring, including one week of blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any subjects who have been taking desvenlafaxine succinate sustained release prior to discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following taper, subjects will be evaluated for one additional week to monitor safety.

Not Provided
Interventional
Phase 3
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
    50 mg tablet, once daily. 5 months open-label duration for all enrolled subjects; additional 6 months double-blind duration for randomized subjects assigned to this arm.
    Other Name: Pristiq
  • Drug: Desvenlafaxine succinate sustained release 25 mg
    25 mg tablet for taper, once daily for 1 week
    Other Name: Pristiq
  • Drug: Placebo
    Matching placebo tablet, once daily. 6 months double-blind duration for randomized subjects assigned to placebo.
  • Experimental: Desvenlafaxine succinate sustained release 50 mg
    Interventions:
    • Drug: Desvenlafaxine succinate sustained release 50 mg
    • Drug: Desvenlafaxine succinate sustained release 25 mg
  • 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
874
March 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening)
  • Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20
  • Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4.

Exclusion Criteria:

  • Significant risk of suicide as assessed by clinician judgment, HAM-D17 and Columbia Suicide-Severity Rating Scale scores.
  • Past treatment with desvenlafaxine succinate sustained release.
  • Other eligibility criteria also apply.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Chile,   Colombia,   Croatia,   Estonia,   Finland,   France,   Latvia,   Lithuania,   Poland,   Romania,   Slovakia,   South Africa,   United States
Argentina
 
NCT00887224
3151A1-3360
B2061004
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

ICMJE     Data element required by the

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

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