Citalopram for Sx/Util in Acute Coronary Syndrome Patients

December 7, 2022 updated by: Mark W. Ketterer, PhD, Henry Ford Health System

Symptoms (chest pain, shortness of breath, dizziness, etc.) and treatment usage (doctor or emergency room visits, testing, hospital days, etc.) in patients with Acute Coronary Syndromes are known to be related to emotional distress (Anxiety, Depression and Anger). In addition, behavioral treatment of emotional distress is known to decrease symptoms, and treatment usage. The present protocol tests whether the addition of a medication known to reduce emotional distress can also reduce symptoms and treatment usage.

This will done by recruiting patients with ACS during their hospital stay, randomizing them to receive citalopram or placebo, and then examining their symptoms and treatment usage at 6 months.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Not applicable. Study not funded.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admission to hospital for chest pain/dyspnea, typical ECG changes plus positive tropinins

Exclusion Criteria:

  • age less than 18
  • cognitive impairment (per MMSE)
  • geographic unavailability for followup
  • unwillingness to participate
  • illiteracy
  • Hx cardiac transplant
  • untreated hypothyroidism
  • hepatic dysfunction
  • prior adverse reaction to citalopram
  • history of Bipolar Disorder
  • untreated Sleep Apnea
  • chronic steroid therapy
  • active substance abuse (e.g., within past year)
  • near term mortal illness
  • current mental health treatment
  • signitificant suicide risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo pill
Drug: Citalopram
10 mg/day
Experimental: Citalopram
Drug
Drug: Citalopram
10 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of ACS Symptoms
Time Frame: 6 months
Frequency of episiodes of chest pain, presyncope, dyspnea, fatigue and palpitations
6 months
Treatment usage
Time Frame: 6 months
ER Visits, Hospital Days, Catheterizations, PTCAs/CABGs, Valve Surgery, AICD/Pacemaker, Treadmills, Echos, Nuclear Scans, Chest X-Rays
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional Distress
Time Frame: 6 months
Depression per PHQ9, Anxiety per GAD7 & Anxiety/Depression/AIAI per KSSFC
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: Mark W Ketterer, PhD, Henry Ford Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2016

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Actual)

February 16, 2021

Study Registration Dates

First Submitted

August 12, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (Estimate)

August 17, 2012

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11146121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Study not funded.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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