Citalopram for Sx/Util in Acute Coronary Syndrome Patients

Study Overview
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Brief Summary
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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
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Not applicable. Study not funded.

Official Title
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Citalopram for Sx/Util in Acute Coronary Syndrome Patients

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Citalopram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo pill | Drug: Citalopram<br>* 10 mg/day<br>|
| Experimental: Citalopram<br>Drug | Drug: Citalopram<br>* 10 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of ACS Symptoms | Frequency of episiodes of chest pain, presyncope, dyspnea, fatigue and palpitations | 6 months | 
| Treatment usage | 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 | Depression per PHQ9, Anxiety per GAD7 & Anxiety/Depression/AIAI per KSSFC | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angina, Acute Coronary Syndrome, Emotional Distress, Citalopram, Health Care Utilization