Preventing Depression in People Receiving Mechanical Ventilation in an Intensive Care Unit

Feasibility Study to Prevent Post-ICU Depression

This study will determine the effectiveness of antidepressant medication in preventing depression and improving recovery in people who have been supported by mechanical ventilators in an intensive care unit (ICU).

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: Escitalopram; Drug: Placebo

Detailed Description

More than one third of all people admitted to ICUs in hospitals require mechanical ventilation for respiratory failure. Many people who survive after being on mechanical ventilation for a prolonged time have significant issues with recovery and quality of life when discharged from the ICU. They are also more prone to depression, which increases patient suffering and the need for medical care, decreases quality of life, and is associated with increased mortality. Previous research indicates that antidepressant medications may improve quality of life and recovery in people who have had a heart attack, but that behavioral treatments are not effective in this case. Treating depression in ICU patients with respiratory failure has not been examined. In this study, antidepressant medications will be given to people who have been on mechanical ventilation in an ICU to determine the effectiveness of antidepressants in improving medical recovery and quality of life. Only a small number of participants will be enrolled in this trial to test the methods and theory; if it is successful, a larger trial will be conducted to determine whether these findings can be widely generalized.

Participation in this study will last 8 weeks, with follow-up assessments lasting for 6 months. Participants on a ventilation machine will be randomly assigned to receive either escitalopram, which is an FDA-approved antidepressant, or a placebo pill. A healthy surrogate may need to enroll participants in the study, because participants will begin treatment while in the ICU and may not be able to make an informed decision. The medication or placebo treatment will last for 2 months, continuing at the participant's home after discharge from the ICU. Dosage levels will begin at 10 mg per day and will be increased to 20 mg per day for some participants after 3 to 5 weeks. Every 2 weeks, participants will complete questionnaires by phone or in person about their medical and psychological symptoms and about whether they are taking the study medication. At 8 weeks, participants will complete an in-person interview about depression symptoms, quality of life, and physical function. At 9 weeks, participants will complete a telephone interview about medication withdrawal. Finally, at 4 and 6 months, participants will complete interviews about depression and general health.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Newly mechanically ventilated via an endotracheal tube
• Expected to remain intubated for at least 48 hours
• Fluent in English or Spanish

Exclusion Criteria:

• Depression before admission to the ICU, as determined by a proxy interview
• Use of antidepressant medication within the last 2 weeks or a monoamine oxidase (MAO) inhibitor in the previous month
• History of suicide attempt
• Ventricular arrhythmias or a seizure requiring medication in the last 6 months
• History of retinal vascular proliferation or bleeding
• Migraine headaches treated with 5-HT1 agonists
• Organ transplant within the last 6 months
• Score of less than 4 on the Glasgow coma scale, in the absence of drug effects, for 2 days
• Acute brain hemorrhage
• Increased intracranial pressure
• Active bleeding or less than 20,000 platelets/ul
• Expected prolonged inability to enterally administer escitalopram
• Residence more than 75 miles from study facility
• Serum sodium less than 125 mEq/l
• Hypersensitivity to citalopram or escitalopram
• Pregnant, breastfeeding, or possibly becoming pregnant in the next 3 months
• Undergoing life-support withdrawal or very low likelihood of 2-month survival
• Cognitive or communication impairment severe enough to preclude a conversation with an interviewer present before admission to ICU

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Participants will receive 8 weeks of escitalopram treatment.	Drug: Escitalopram; 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents; Other Names: Lexapro
Placebo Comparator: 2; Participants will receive 8 weeks of placebo pills.	Drug: Placebo; Placebo pills for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recruitment Feasibility, Defined as the Number of Participants Recruited and Administered a Medication Dose Within 48 Hours of Mechanical Ventilation	Measured within 2 days of participant recruitment

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Craig Weinert, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: March 30, 2009
• First Submitted That Met QC Criteria: March 30, 2009
• First Posted (Estimate): March 31, 2009

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Critical Illness; Acute Respiratory Failure; Prolonged Mechanical Ventilation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: R34MH082156 (U.S. NIH Grant/Contract); DSIR 83 ATP