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NCT01537068 · ClinicalTrials.gov registry record · Phase 4
Desvenlafaxine vs. Placebo Treatment of Chronic Depression
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 59
- Enrollment target
NCT01537068: Completed Phase 4 study, sponsored by New York State Psychiatric Institute.
NCT01537068 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 59 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01537068, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 59 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Desvenlafaxine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-12 |
| Phase | Phase 4 |
What the finished NCT01537068 record still lists
NCT01537068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01537068 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01537068 about?
NCT01537068 is a clinical study titled "Desvenlafaxine vs. Placebo 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 effe...
What is the current status of trial NCT01537068?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 59 participants. The study started on 2012-02. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01537068?
The interventions under investigation include: Placebo (DRUG), Desvenlafaxine (DRUG).
Who is sponsoring clinical trial NCT01537068?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01537068's enrollment target sits among peer trials
59 1202nd of 2000 higher than 796 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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