Citalopram for Sx/Util in Acute Coronary Syndrome Patients

NCT01667744 | Withdrawn Phase 1 DMC

• 1 other identifier: 11146121
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Emotional Distress

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo pill

Drug: Citalopram

Citalopram

EXPERIMENTAL

Drug

Drug: Citalopram

Interventions

Citalopram DRUG

10 mg/day

Citalopram; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to hospital for chest pain/dyspnea, typical ECG changes plus positive tropinins

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Angina Pectoris; Patient Acceptance of Health Care

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mark W Ketterer, PhD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Bioscientific Staff

Study Record Dates

• First Submitted: August 12, 2012
• First Posted: August 17, 2012
• Study Start: January 1, 2016
• Primary Completion: February 1, 2016
• Study Completion: February 16, 2021
• Last Updated: December 9, 2022

Record last verified: 2022-12

Locations

US (1)