Citalopram for Sx/Util in Acute Coronary Syndrome Patients
Information source: Henry Ford Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Coronary Syndrome
Intervention: Citalopram (Drug)
Phase: Phase 1/Phase 2
Status: Not yet recruiting
Sponsored by: Henry Ford Health System Official(s) and/or principal investigator(s):
Mark W Ketterer, PhD, Principal Investigator, Affiliation: Henry Ford Health System
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.
Clinical Details
Official title: Citalopram for Sx/Util in Acute Coronary Syndrome Patients
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Frequency of ACS SymptomsTreatment usage
Secondary outcome: Emotional Distress
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Henry Ford Hospital, Detroit, Michigan 48202, United States
Additional Information
Starting date: January 2018
Last updated: March 17, 2015
|
