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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
  Purpose

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.


Condition Intervention Phase
Dysthymic Disorder Dysthymia Chronic Depressive Disorder Drug: Desvenlafaxine Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Desvenlafaxine (Pristiq) vs. Placebo in the Treatment of Chronic Depression

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 59
Actual Study Start Date: February 2012
Study Completion Date: December 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desvenlafaxine
Serotonin-norepinephrine reuptake inhibitors (SNRIs) antidepressant drug
Drug: Desvenlafaxine
Desvenlafaxine oral dose ranging from 50 to 100 mg/day
Other Name: Pristiq
Placebo Comparator: Placebo
Placebo treatment
Drug: Placebo
Matching placebo pills
Other Name: Inactive comparator

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537068


Locations
United States, New York
New York State Psychiatric Institute/3 Columbus Circle Midtown
New York, New York, United States, 10019
Depression Evaluation Service (DES), New York State Psychiatric Institute, Columbia University Department of Psychiatry
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Pfizer
Investigators
Principal Investigator: David J Hellerstein, MD New York State Psychiatric Institute, Columbia University Department of Psychiatry
  More Information

Additional Information:
Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01537068     History of Changes
Other Study ID Numbers: #6457 Pfizer-WS1895577
First Submitted: February 16, 2012
First Posted: February 22, 2012
Results First Submitted: June 12, 2017
Results First Posted: September 11, 2017
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by New York State Psychiatric Institute:
Dysthymic disorder
Dysthymia
Chronic non-major depression
Non-major chronic depression
Chronic depressive disorder
Antidepressant treatment

Additional relevant MeSH terms:
Disease
Depression
Depressive Disorder
Dysthymic Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs