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Desvenlafaxine vs. Placebo Treatment of Chronic Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by New York State Psychiatric Institute
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
David J. Hellerstein, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01537068
First received: February 16, 2012
Last updated: April 16, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 - 24 item version (HDRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Clinician-rated Depression rating scale


Secondary Outcome Measures:
  • Clinical Global Improvement Scale (CGI-I) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assessment of overall improvement

  • Cornell Dysthymia Rating Scale (CDRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Patient-rated Depression symptoms

  • Beck Depression Inventory (BDI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Patient-rated Depression symptoms

  • Columbia Suicide Severity Rating Scale (C-SSRS; Posner, et al., 2007) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Clinician rated Suicide ideation and behaviors scale


Estimated Enrollment: 60
Study Start Date: February 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desvenlafaxine
SNRI 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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537068

Contacts
Contact: Donna O'Shea, BS 646-774-7946 osheado@nyspi.columbia.edu

Locations
United States, New York
Depression Evaluation Service (DES), New York State Psychiatric Institute, Columbia University Department of Psychiatry Recruiting
New York, New York, United States, 10032
Contact: Mark Rodriguez, BA    646-774-8000    desdesk@nyspi.columbia.edu   
Contact: Donna O'Shea, BS    646-774-7946    osheado@nyspi.columbia.edu   
Principal Investigator: David J Hellerstein, MD         
New York State Psychiatric Institute/3 Columbus Circle Midtown Recruiting
New York, New York, United States, 10019
Contact: Mark Rodriguez, BA    646-774-8000    desdesk@nyspi.columbia.edu   
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: David J. Hellerstein, Professor of Clinical Psychiatry, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01537068     History of Changes
Other Study ID Numbers: #6457 Pfizer-WS1895577
Study First Received: February 16, 2012
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

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:
Dysthymic Disorder
Depression
Depressive Disorder
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
O-desmethylvenlafaxine
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014