Desvenlafaxine vs. Placebo Treatment of Chronic Depression

• ClinicalTrials.gov Identifier: NCT01537068
• Recruitment Status: Completed
• First Posted: February 22, 2012
• Results First Posted: September 11, 2017
• Last Update Posted: September 11, 2017
• Sponsor: New York State Psychiatric Institute
• Collaborator: Pfizer
• Information provided by (Responsible Party): New York State Psychiatric Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dysthymic Disorder; Dysthymia; Chronic Depressive Disorder	Drug: Desvenlafaxine; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 59 participants
• 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
• Actual Study Start Date: February 2012
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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 :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 65 Years (Adult, Older 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

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:

Depression Evaluation Service, NY State Psychiatric Institute website 

Columbia Psychiatry website, clinical trials 

Publications:

DeMartinis NA, Yeung PP, Entsuah R, Manley AL. A double-blind, placebo-controlled study of the efficacy and safety of desvenlafaxine succinate in the treatment of major depressive disorder. J Clin Psychiatry. 2007 May;68(5):677-88. doi: 10.4088/jcp.v68n0504.

Levkovitz Y, Tedeschini E, Papakostas GI. Efficacy of antidepressants for dysthymia: a meta-analysis of placebo-controlled randomized trials. J Clin Psychiatry. 2011 Apr;72(4):509-14. doi: 10.4088/JCP.09m05949blu.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yang J, Hellerstein DJ, Chen Y, McGrath PJ, Stewart JW, Peterson BS, Wang Z. Serotonin-norepinephrine reuptake inhibitor antidepressant effects on regional connectivity of the thalamus in persistent depressive disorder: evidence from two randomized, double-blind, placebo-controlled clinical trials. Brain Commun. 2022 Apr 15;4(3):fcac100. doi: 10.1093/braincomms/fcac100. eCollection 2022.

Hellerstein DJ, Stewart JW, Chen Y, Arunagiri V, Peterson BS, McGrath PJ. Desvenlafaxine vs. placebo in the treatment of persistent depressive disorder. J Affect Disord. 2019 Feb 15;245:403-411. doi: 10.1016/j.jad.2018.11.065. Epub 2018 Nov 5.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT01537068
• Other Study ID Numbers: #6457 Pfizer-WS1895577
• First Posted: February 22, 2012
• 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