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NCT01625845 · ClinicalTrials.gov registry record · Phase 2
Anti-INFLammatory to Address Mood and Endothelial Dysfunction (INFLAMED)
A Phase 2 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01625845: Completed Phase 2 study, sponsored by Indiana University.
NCT01625845 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01625845, a Phase 2 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
The objective of this clinical trial is to evaluate whether an anti-inflammatory medication, pentoxifylline, reduces depressive symptoms and improves artery function. Participants in this trial will be older primary care patients (60 years and up) who are depressed but do not have a history of cardiovascular disease. Half of these patients will receive pentoxifylline, and half will receive placebo. In addition, participants in both arms will receive an evidence-based psychological treatment called Beating the Blues®, which is a computerized, cognitive behavioral treatment program for depression. The investigators will use questionnaires to assess change in depressive symptoms and an ultrasound test to measure change in artery function from pre- to post-treatment. It is hypothesized that patients who receive pentoxifylline will show greater improvements in both depression and artery function than patients who receive placebo.
Primary Outcome
Patients underwent ultrasound assessment of brachial FMD in accordance with established guidelines at pre- (0 weeks) and post- (12 weeks) treatment. After a 10-minute supine rest, high-resolution baseline images of the brachial artery were obtained from 3 consecutive cardiac cycles. Next, the forearm cuff was inflated to 250 mmHg for 5 minutes and then was rapidly deflated. At 60 and 90 seconds post-deflation, images from 3 consecutive cardiac cycles were acquired. FMD values were computed as th
Interventions
- OTHER Placebo
- DRUG Pentoxifylline
- BEHAVIORAL Standard Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
What the finished NCT01625845 record still lists
NCT01625845 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01625845 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01625845 about?
NCT01625845 is a clinical study titled "Anti-INFLammatory to Address Mood and Endothelial Dysfunction (INFLAMED)". The objective of this clinical trial is to evaluate whether an anti-inflammatory medication, pentoxifylline, reduces depressive symptoms and improves artery function. Participants in this trial will be older primary care patients (60 years and up) who are depressed but do not have a history of cardi...
What is the current status of trial NCT01625845?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2012-06. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01625845?
The interventions under investigation include: Placebo (OTHER), Pentoxifylline (DRUG), Standard Treatment (BEHAVIORAL).
Who is sponsoring clinical trial NCT01625845?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01625845's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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