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Citalopram for Sx/Util in Acute Coronary Syndrome Patients

Primary Purpose

Acute Coronary Syndrome

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Citalopram
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Angina, Acute Coronary Syndrome, Emotional Distress, Citalopram, Health Care Utilization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henry Ford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Citalopram

Arm Description

Placebo pill

Drug

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Emotional Distress
Depression per PHQ9, Anxiety per GAD7 & Anxiety/Depression/AIAI per KSSFC

Full Information

First Posted
August 12, 2012
Last Updated
December 7, 2022
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT01667744
Brief Title
Citalopram for Sx/Util in Acute Coronary Syndrome Patients
Official Title
Citalopram for Sx/Util in Acute Coronary Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
unfunded
Study Start Date
January 1, 2016 (Anticipated)
Primary Completion Date
February 1, 2016 (Anticipated)
Study Completion Date
February 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Not applicable. Study not funded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Angina, Acute Coronary Syndrome, Emotional Distress, Citalopram, Health Care Utilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo pill
Arm Title
Citalopram
Arm Type
Experimental
Arm Description
Drug
Intervention Type
Drug
Intervention Name(s)
Citalopram
Intervention Description
10 mg/day
Primary Outcome Measure Information:
Title
Frequency of ACS Symptoms
Description
Frequency of episiodes of chest pain, presyncope, dyspnea, fatigue and palpitations
Time Frame
6 months
Title
Treatment usage
Description
ER Visits, Hospital Days, Catheterizations, PTCAs/CABGs, Valve Surgery, AICD/Pacemaker, Treadmills, Echos, Nuclear Scans, Chest X-Rays
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Emotional Distress
Description
Depression per PHQ9, Anxiety per GAD7 & Anxiety/Depression/AIAI per KSSFC
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark W Ketterer, PhD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Study not funded.

Learn more about this trial

Citalopram for Sx/Util in Acute Coronary Syndrome Patients

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