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Comparison of Depression Interventions After Acute Coronary Syndrome
NCT01032018 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01032018
The ClinicalTrials.gov registry entry for NCT01032018 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 875 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01032018 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Connecticut, Georgia, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01032018?
This trial is sponsored by Columbia University, which has 875 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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