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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 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.

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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.

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

FieldValue
Enrollment Target 150 participants
Start Date 2010-01
Est. Completion 2012-07
Phase Phase 1

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT01032018

The ClinicalTrials.gov registry entry for NCT01032018 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (81% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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