- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01537068
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.
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10019
- New York State Psychiatric Institute/3 Columbus Circle Midtown
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New York, New York, United States, 10032
- Depression Evaluation Service (DES), New York State Psychiatric Institute, Columbia University Department of Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Desvenlafaxine
Serotonin-norepinephrine reuptake inhibitors (SNRIs) antidepressant drug
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Desvenlafaxine oral dose ranging from 50 to 100 mg/day
Other Names:
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Placebo Comparator: Placebo
Placebo treatment
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Matching placebo pills
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Baseline
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Hamilton Rating Scale for Depression (HDRS24)
Time Frame: Week 12
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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
|
Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate
Time Frame: 12 weeks
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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.
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12 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David J Hellerstein, MD, New York State Psychiatric Institute, Columbia University Department of Psychiatry
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Disease
- Dysthymic Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Desvenlafaxine Succinate
Other Study ID Numbers
- #6457 Pfizer-WS1895577
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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