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Citalopram for Sx/Util in Acute Coronary Syndrome Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Henry Ford Health System
Sponsor:
Information provided by (Responsible Party):
Mark W. Ketterer, PhD, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01667744
First received: August 12, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Acute Coronary Syndrome
Drug: Citalopram
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Citalopram for Sx/Util in Acute Coronary Syndrome Patients

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Frequency of ACS Symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Frequency of episiodes of chest pain, presyncope, dyspnea, fatigue and palpitations

  • Treatment usage [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    ER Visits, Hospital Days, Catheterizations, PTCAs/CABGs, Valve Surgery, AICD/Pacemaker, Treadmills, Echos, Nuclear Scans, Chest X-Rays


Secondary Outcome Measures:
  • Emotional Distress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Depression per PHQ9, Anxiety per GAD7 & Anxiety/Depression/AIAI per KSSFC


Estimated Enrollment: 200
Study Start Date: February 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo pill
Drug: Citalopram
10 mg/day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667744

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

No publications provided

Responsible Party: Mark W. Ketterer, PhD, Senior Bioscientific Staff, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01667744     History of Changes
Other Study ID Numbers: 11146121
Study First Received: August 12, 2012
Last Updated: August 14, 2012
Health Authority: United States: Federal Government

Keywords provided by Henry Ford Health System:
Angina
Acute Coronary Syndrome
Emotional Distress
Citalopram
Health Care Utilization

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014