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Citalopram for Sx/Util in Acute Coronary Syndrome Patients

Citalopram for Sx/Util in Acute Coronary Syndrome Patients

Status
Withdrawn
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01667744
Enrollment
0
Registered
2012-08-17
Start date
2016-01-01
Completion date
2021-02-16
Last updated
2022-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

Angina, Acute Coronary Syndrome, Emotional Distress, Citalopram, Health Care Utilization

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.

Interventions

DRUGCitalopram

10 mg/day

Sponsors

Henry Ford Health System
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of ACS Symptoms6 monthsFrequency of episiodes of chest pain, presyncope, dyspnea, fatigue and palpitations
Treatment usage6 monthsER Visits, Hospital Days, Catheterizations, PTCAs/CABGs, Valve Surgery, AICD/Pacemaker, Treadmills, Echos, Nuclear Scans, Chest X-Rays

Secondary

MeasureTime frameDescription
Emotional Distress6 monthsDepression per PHQ9, Anxiety per GAD7 & Anxiety/Depression/AIAI per KSSFC

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026