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Clinical trialNCT01537068CompletedPhase 4Interventional

Desvenlafaxine vs. Placebo Treatment of Chronic Depression

SponsorNew York State Psychiatric InstituteEnrollment59Chronic Depressive DisorderDysthymiaDysthymic Disorder
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • David J Hellerstein, MD

    New York State Psychiatric Institute, Columbia University Department of Psychiatry

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Depression Evaluation Service (des), New York State Psychiatric Institute, Columbia University Department of Psychiatry

    New York, New York, United States

  • New York State Psychiatric Institute/3 Columbus Circle Midtown

    New York, New York, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
29 Feb 2012
Primary completion
31 Aug 2016
Completion
31 Dec 2016
Last update posted
11 Sept 2017
Registered enrollment
59
Registry id
NCT01537068

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.