Citalopram for Sx/Util in Acute Coronary Syndrome Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01667744
Recruitment Status : Withdrawn (unfunded)
First Posted : August 17, 2012
Last Update Posted : February 19, 2016
Information provided by (Responsible Party):
Mark W. Ketterer, PhD, 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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Citalopram Phase 1 Phase 2

Detailed Description:
Not applicable. Study not funded.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Citalopram for Sx/Util in Acute Coronary Syndrome Patients
Study Start Date : January 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo pill
Drug: Citalopram
10 mg/day

Primary Outcome Measures :
  1. Frequency of ACS Symptoms [ Time Frame: 6 months ]
    Frequency of episiodes of chest pain, presyncope, dyspnea, fatigue and palpitations

  2. Treatment usage [ Time Frame: 6 months ]
    ER Visits, Hospital Days, Catheterizations, PTCAs/CABGs, Valve Surgery, AICD/Pacemaker, Treadmills, Echos, Nuclear Scans, Chest X-Rays

Secondary Outcome Measures :
  1. Emotional Distress [ Time Frame: 6 months ]
    Depression per PHQ9, Anxiety per GAD7 & Anxiety/Depression/AIAI per KSSFC

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01667744

United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Principal Investigator: Mark W Ketterer, PhD Henry Ford Health System

Responsible Party: Mark W. Ketterer, PhD, Senior Bioscientific Staff, Henry Ford Health System Identifier: NCT01667744     History of Changes
Other Study ID Numbers: 11146121
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Study not funded.

Keywords provided by Mark W. Ketterer, PhD, Henry Ford Health System:
Acute Coronary Syndrome
Emotional Distress
Health Care Utilization

Additional relevant MeSH terms:
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents