Citalopram for Sx/Util in Acute Coronary Syndrome Patients

Phase 1

Withdrawn

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Citalopram

• Registration Number: NCT01667744
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study First Submitted: 2012-08-12
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-17
• Study Start: 2016-01-01
• Primary Completion: 2016-02-01
• Study Completion: 2021-02-16
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Citalopram	Citalopram	Drug
Placebo	Citalopram	Placebo pill

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Emotional Distress	6 months	Depression per PHQ9, Anxiety per GAD7 \& Anxiety/Depression/AIAI per KSSFC

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States