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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 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 36 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01625845
The ClinicalTrials.gov registry entry for NCT01625845 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01625845 reports 0 study locations.
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.
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