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Citalopram for Sx/Util in Acute Coronary Syndrome Patients

NCT ID: NCT01667744

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2021-02-16

Brief Summary

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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

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Not applicable. Study not funded.

Conditions

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Acute Coronary Syndrome

Keywords

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Angina Acute Coronary Syndrome Emotional Distress Citalopram Health Care Utilization

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Placebo

Placebo pill

Group Type PLACEBO_COMPARATOR

Citalopram

Intervention Type DRUG

10 mg/day

Citalopram

Drug

Group Type EXPERIMENTAL

Citalopram

Intervention Type DRUG

10 mg/day

Interventions

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Citalopram

10 mg/day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Mark W. Ketterer, PhD

Senior Bioscientific Staff

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark W Ketterer, PhD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

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Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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11146121

Identifier Type: -

Identifier Source: org_study_id