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

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute Identifier:
First received: March 30, 2009
Last updated: February 15, 2017
Last verified: February 2017
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).

Condition Intervention Phase
Drug: Escitalopram
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official Title: Feasibility Study to Prevent Post-ICU Depression

Resource links provided by NLM:

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

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

Secondary Outcome Measures:
  • Proportion of Planned Study Doses Actually Administered to Participants [ Time Frame: Measured after 8 weeks ]
  • Proportion of Completed Interviews, Excluding Follow-ups [ Time Frame: Measured after 8 weeks ]
  • Participant Reconsent Rate [ Time Frame: Measured after 8 weeks ]
  • Proportion of Participants Enrolled Compared to All Eligible Participants [ Time Frame: Measured 1 day after recruitment ]
  • Rate, Timing, and Tolerability of Medication Dose Escalation to 20 mg [ Time Frame: Measured after 5 weeks ]
  • Rate of Off-protocol Antidepressant Use [ Time Frame: Measured after 8 weeks ]
  • Success of Experimental Medication Blinding [ Time Frame: Measured after 8 weeks ]
  • Depression Severity, Measured by Center for Epidemiological Studies Depression Scale (CES-D), Between the Two Arms [ Time Frame: Measured after 8 weeks ]
  • Depression Severity, Measured by the 17-item Hamilton Depression Scale (HAM-D17) [ Time Frame: Measured after 8 weeks ]
  • Depression Severity, Measured by Montgomery Åsberg Depression Rating Scale (MADRS) [ Time Frame: Measured after 8 weeks ]
  • Rate of Suicide Attempts and Suicidal Ideation [ Time Frame: Measured after 8 weeks ]
  • Rate and Severity of Medication Withdrawal Symptoms [ Time Frame: Measured after 9 weeks ]
  • Proportion of Major Depressive Episodes and Incidences of Major Depressive Disorder, Measured by the Structured Clinical Interview for DSM-IV (SCID) [ Time Frame: Measured after 8 weeks ]
  • Quality of Life, Measured by the 12-item Short Form Health Survey (SF-12) [ Time Frame: Measured after 8 weeks ]
  • Rates of Adverse Events, Serious Adverse Events, and Deaths After the End of Treatment [ Time Frame: Measured after 12 weeks ]
  • Participant Burden, Defined as the Time Taken for Completion of the Study Questionnaires [ Time Frame: Measured after 12 weeks ]

Enrollment: 37
Study Start Date: April 2009
Study Completion Date: July 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lexapro
Placebo Comparator: 2
Participants will receive 8 weeks of placebo pills.
Drug: Placebo
Placebo pills for 8 weeks

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.


Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00872027

United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Mental Health (NIMH)
Principal Investigator: Craig Weinert, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute Identifier: NCT00872027     History of Changes
Other Study ID Numbers: R34MH082156 ( US NIH Grant/Contract Award Number )
Study First Received: March 30, 2009
Results First Received: February 15, 2017
Last Updated: February 15, 2017

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Critical Illness
Intensive Care Unit
Acute Respiratory Failure
Prolonged Mechanical Ventilation

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
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 processed this record on April 28, 2017