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NCT01032018 · ClinicalTrials.gov registry record · Phase 1
Comparison of Depression Interventions After Acute Coronary Syndrome
A Phase 1 study of Depression and Acute Coronary Syndrome, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
- 5
- Study locations
NCT01032018: Completed Phase 1 study of Depression and Acute Coronary Syndrome, sponsored by Columbia University.
NCT01032018 is a Phase 1 study of Depression and Acute Coronary Syndrome that has completed, run by Columbia University. The registered enrollment target is 150 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (81% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01032018, a Phase 1 study of Depression and Acute Coronary Syndrome, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
- 5
- Study locations
Study Summary
Patients will be consented and screened within 2 to 6 months of the index ACS. Patients who have elevated depression (BDI\>=15 or BDI\>=10 assessed twice over two week period) and who continue to meet all of the trial's eligibility criteria will be consented. Through informed consent, both arms of the trial will be described with equipoise as to these approaches to postACS depression care. Patients who consent to randomization will be enrolled in the treatment trial. The intervention phase will be 6 months, and hence the final outcome assessments will be performed approximately 9 months after the index ACS. Interim measures of depression will be obtained at 2 and 4 months post-enrollment. Major adverse cardiac events and all-cause mortality will also be ascertained at 6 months post-enrollment. Quality assurance by an independent medical event adjudication committee using prospective guidelines will be employed.
Primary Outcome
Symptoms of depression were assessed using the Beck Depression Inventory (BDI). This 21-question, multiple choice self-report instrument includes items pertaining to symptoms of depression, including hopelessness and irritability, physical symptoms such as fatigue, and thoughts such as guilt. Each item has at a set of four possible responses, ranging in intensity for least intense to most intense. The total score is calculated by adding the responses to each item. Higher scores indicate more sev
Conditions Studied
Interventions
- OTHER Standard care
- BEHAVIORAL Problem Solving Therapy
- DRUG Sertraline, citalopram, or bupropion
Study Locations (5)
Connecticut
- Yale University - New Haven
Georgia
- Emory University - Atlanta
Missouri
- Washington University - St Louis
New York
- Columbia University Medical Center - New York
Pennsylvania
- Trustees of the University of Pennsylvania, Penn Cardiac Center at Mercer Bucks - Yardley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
What the finished NCT01032018 record still lists
NCT01032018 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 3 interventions - of which Standard care is the first listed.
NCT01032018 lists 5 locations in 5 states (Connecticut, Georgia, Missouri).
Frequently Asked Questions
What is clinical trial NCT01032018 about?
NCT01032018 is a clinical study titled "Comparison of Depression Interventions After Acute Coronary Syndrome". Patients will be consented and screened within 2 to 6 months of the index ACS. Patients who have elevated depression (BDI\>=15 or BDI\>=10 assessed twice over two week period) and who continue to meet all of the trial's eligibility criteria will be consented. Through informed consent, both arms of t...
What is the current status of trial NCT01032018?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2010-01. Estimated completion is 2012-07.
What conditions does trial NCT01032018 study?
This clinical trial studies the following conditions: Depression, Acute Coronary Syndrome.
What interventions are being tested in trial NCT01032018?
The interventions under investigation include: Standard care (OTHER), Problem Solving Therapy (BEHAVIORAL), Sertraline, citalopram, or bupropion (DRUG).
Who is sponsoring clinical trial NCT01032018?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01032018 being conducted?
This trial has 5 study locations across Connecticut, Georgia, Missouri, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01032018's enrollment target sits among peer trials
150 249th of 679 higher than 416 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression 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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