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Desvenlafaxine vs. Placebo Treatment of Chronic Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01537068
First Posted: February 22, 2012
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
New York State Psychiatric Institute
February 16, 2012
February 22, 2012
June 12, 2017
September 11, 2017
September 11, 2017
February 2012
August 2016   (Final data collection date for primary outcome measure)
  • Hamilton Rating Scale for Depression (HDRS24) [ Time Frame: Baseline ]
    HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression
  • Hamilton Rating Scale for Depression (HDRS24) [ Time Frame: Week 12 ]
    HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression
Hamilton Rating Scale for Depression - 24 item version [ Time Frame: 12 weeks ]
Clinician-rated Depression rating scale
Complete list of historical versions of study NCT01537068 on ClinicalTrials.gov Archive Site
Response Rate [ Time Frame: 12 weeks ]
Assessment of overall improvement: based on HDRS and Clinical Global Improvement Scale Response Rate is defined as 50% improvement of Hamd24 summary scores from baseline.
  • Clinical Global Improvement Scale [ Time Frame: 12 weeks ]
    Assessment of overall improvement
  • Cornell Dysthymia Rating Scale [ Time Frame: 12 weeks ]
    Clinician-rated Depression rating scale for symptoms of chronic low-grade depression
  • Quick Inventory of Depressive Symptomatology-Self-Rated version (QIDS-SR) [ Time Frame: 12 weeks ]
    Patient-rated Depression symptoms
  • Beck Depression Inventory (BDI) [ Time Frame: 12 weeks ]
    Patient-rated Depression symptoms
  • Columbia Suicide Severity Rating Scale (C-SSRS; Posner, et al., 2007) [ Time Frame: 12 weeks ]
    Clinician rated Suicide ideation and behaviors scale
Not Provided
Not Provided
 
Desvenlafaxine vs. Placebo Treatment of Chronic Depression
Desvenlafaxine (Pristiq) vs. Placebo in the Treatment of Chronic Depression

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Dysthymic Disorder
  • Dysthymia
  • Chronic Depressive Disorder
  • Drug: Desvenlafaxine
    Desvenlafaxine oral dose ranging from 50 to 100 mg/day
    Other Name: Pristiq
  • Drug: Placebo
    Matching placebo pills
    Other Name: Inactive comparator
  • Experimental: Desvenlafaxine
    Serotonin-norepinephrine reuptake inhibitors (SNRIs) antidepressant drug
    Intervention: Drug: Desvenlafaxine
  • Placebo Comparator: Placebo
    Placebo treatment
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
December 2016
August 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01537068
#6457 Pfizer-WS1895577
No
Not Provided
Plan to Share IPD: No
New York State Psychiatric Institute
New York State Psychiatric Institute
Pfizer
Principal Investigator: David J Hellerstein, MD New York State Psychiatric Institute, Columbia University Department of Psychiatry
New York State Psychiatric Institute
September 2017

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