Citalopram for Sx/Util in Acute Coronary Syndrome Patients

Acute Coronary Syndrome Clinical Trial

Official title:

Citalopram for Sx/Util in Acute Coronary Syndrome Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01667744
• Other study ID #: 11146121
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: January 1, 2016
• Est. completion date: February 16, 2021

Study information

• Verified date: December 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Not applicable. Study not funded.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 16, 2021
• Est. primary completion date: February 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Citalopram
10 mg/day

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of ACS Symptoms	Frequency of episiodes of chest pain, presyncope, dyspnea, fatigue and palpitations	6 months
Primary	Treatment usage	ER Visits, Hospital Days, Catheterizations, PTCAs/CABGs, Valve Surgery, AICD/Pacemaker, Treadmills, Echos, Nuclear Scans, Chest X-Rays	6 months
Secondary	Emotional Distress	Depression per PHQ9, Anxiety per GAD7 & Anxiety/Depression/AIAI per KSSFC	6 months