CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 59 enrolled
Drug / intervention
Desvenlafaxine +1 moredrug
Likely dose
Desvenlafaxine 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01537068
NCT01537068Phase 4Completed

Desvenlafaxine (Pristiq) vs. Placebo in the Treatment of Chronic Depression

New York State Psychiatric Institute·interventional·Posted Feb 22, 2012·Updated Sep 11, 2017

In Brief

A Phase 4 clinical trial evaluating Desvenlafaxine and Placebo for Dysthymic Disorder and 2 related conditions. Completed, enrolled 59 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 22, 2012
Enrollment StartFeb 1, 2012
Primary CompletionAug 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 14.4 years ago

Interventions

Desvenlafaxinedrug

Desvenlafaxine oral dose ranging from 50 to 100 mg/day

Placebodrug

Matching placebo pills