Desvenlafaxine vs. Placebo Treatment of Chronic Depression

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Retrospective Study Evaluating The Current Utilization Of Desvenlafaxine Succinate Sustained-Release (Pristiq) Among Psychiatrists And Primary Care Physicians In The Treatment Of Patients With Major Depressive Disorder

NCT01221935

Major Depressive Disorder

COMPLETED

12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder

NCT01316302

Social Anxiety Disorder

COMPLETED PHASE4

Study of Desvenlafaxine in Treating Major Depressive Disorder.

NCT04364997

Major Depressive Disorder

COMPLETED PHASE3

Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder

NCT00300378

Depressive Disorder, Major

COMPLETED PHASE3

An 8 Week Depression Study In Adults Diagnosed With Major Depressive Disorder

NCT00057239

Major Depressive Disorder (MDD)

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dysthymic Disorder Dysthymia Chronic Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Desvenlafaxine

Serotonin-norepinephrine reuptake inhibitors (SNRIs) antidepressant drug

Group Type EXPERIMENTAL

Desvenlafaxine

Intervention Type DRUG

Desvenlafaxine oral dose ranging from 50 to 100 mg/day

Placebo

Placebo treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo pills

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Desvenlafaxine

Desvenlafaxine oral dose ranging from 50 to 100 mg/day

Intervention Type DRUG

Placebo

Matching placebo pills

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pristiq Inactive comparator

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No