Desvenlafaxine vs. Placebo Treatment of Chronic Depression

NCT01537068

Last updated date
Study Location
New York State Psychiatric Institute/3 Columbus Circle Midtown
New York, New York, 10019, 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.
Dysthymic Disorder, Dysthymia, Chronic Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female outpatients 20 to 65 years of age, inclusive

- Principal DSM-5 diagnosis of unipolar non-major Chronic Depressive Disorder (including Major Depression in partial remission, Major Depression, residual, Dysthymic Disorder, or Depressive Disorder NOS)

- Minimum of 2 years duration of the current episode of depressive disorder.

- Score of 12 or higher on the Hamilton Depression Scale (24 items) at baseline

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


- Full remission of depression in past 24 months


- Current major depression diagnosis, psychotic illness


- Current risk of suicide


- Drug or alcohol abuse/dependence in past 6 months


- Active medical illness


- Prior nonresponse to desvenlafaxine


- Medical illness contraindicating use of desvenlafaxine


- Current or planned pregnancy during study period

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Dysthymic Disorder, Dysthymia, Chronic Depressive DisorderDesvenlafaxine vs. Placebo Treatment of Chronic Depression
NCT01537068
  1. New York, New York
  2. New York, New York
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Desvenlafaxine vs. Placebo Treatment of Chronic Depression
Official Title  ICMJE Desvenlafaxine (Pristiq) vs. Placebo in the Treatment of Chronic Depression
Brief Summary

The investigators are studying a new antidepressant medicine, desvenlafaxine, for the treatment of people with chronic depression. Desvenlafaxine (trade name Pristiq) has been approved by the FDA for the treatment of major depression.

The investigators are testing whether this medicine is also effective for adults with a type of chronic depression that is less severe than major depression. This condition is also known as dysthymic disorder or dysthymia. Chronic depression, lasting two or more years, often causes significant suffering and impairment.

In addition, the investigators are using MRI imaging, which uses magnetic signals to make pictures of the brain's structure and also of its functioning. The purpose of MRI imaging in this study is to see whether chronic depression is associated with differences in brain structure or functioning, and whether such differences change after medication or placebo treatment. To test this MRI scans are done at the start of the study and after 12 weeks of medication or placebo treatment. Getting MRI imaging will be an option for participants in this study but is not required.

This study involves a 6 to 12 week double-blind period during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). After the double blind phase, all subjects can be treated for 12 weeks with an FDA-approved antidepressant medication.

Assessments (of depressive symptoms, social functioning, and personality) will be done by study staff and by patients before the study starts, at each study visit for the first 12 weeks, and again after 24 weeks in the study.

Detailed Description

The investigators wish to study acute efficacy for 12 weeks on a double blind basis and continued response after open-label treatment at week 24 follow-up. It is important to establish the acute (12 week) efficacy of desvenlafaxine in non-major chronic depression. Also, given that non-major chronic depression is by definition chronic, it is important to demonstrate that benefit persists at follow-up assessment (24 weeks); this is clinically important in trying to alleviate the significant psychosocial morbidity associated with this disorder.

The investigators believe this study will have significant value in the treatment of patients with non-major chronic depression, and will add significantly to what remains an extremely small scientific literature.

The investigators would also like to study the effects of desvenlafaxine on brain structure and function. Learning that a medication reduces symptoms does not teach us how the medication achieves this outcome. Participants in this study can have the opportunity to participate in MRI scanning that will help to understand the mechanisms by with desvenlafaxine is effective. MRI scans are done prior to starting the clinical trial and then again after completing the double blind clinical trial.

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
  • Dysthymic Disorder
  • Dysthymia
  • Chronic Depressive Disorder
Intervention  ICMJE
  • Drug: Desvenlafaxine
    Desvenlafaxine oral dose ranging from 50 to 100 mg/day
    Other Name: Pristiq
  • Drug: Placebo
    Matching placebo pills
    Other Name: Inactive comparator
Study Arms  ICMJE
  • Experimental: Desvenlafaxine
    Serotonin-norepinephrine reuptake inhibitors (SNRIs) antidepressant drug
    Intervention: Drug: Desvenlafaxine
  • Placebo Comparator: Placebo
    Placebo treatment
    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 7, 2017)
59
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2012)
60
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female outpatients 20 to 65 years of age, inclusive
  • Principal DSM-5 diagnosis of unipolar non-major Chronic Depressive Disorder (including Major Depression in partial remission, Major Depression, residual, Dysthymic Disorder, or Depressive Disorder NOS)
  • Minimum of 2 years duration of the current episode of depressive disorder.
  • Score of 12 or higher on the Hamilton Depression Scale (24 items) at baseline

Exclusion Criteria:

  • Full remission of depression in past 24 months
  • Current major depression diagnosis, psychotic illness
  • Current risk of suicide
  • Drug or alcohol abuse/dependence in past 6 months
  • Active medical illness
  • Prior nonresponse to desvenlafaxine
  • Medical illness contraindicating use of desvenlafaxine
  • Current or planned pregnancy during study period
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 65 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01537068
Other Study ID Numbers  ICMJE #6457 Pfizer-WS1895577
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:David J Hellerstein, MDNew York State Psychiatric Institute, Columbia University Department of Psychiatry
PRS Account New York State Psychiatric Institute
Verification Date September 2017

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