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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00872027
First Posted: March 31, 2009
Last Update Posted: July 11, 2017
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
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
Depression Drug: Escitalopram Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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 ]

Enrollment: 15
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.

  Eligibility

Information from the National Library of Medicine

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00872027


Locations
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)
Investigators
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
ClinicalTrials.gov Identifier: NCT00872027     History of Changes
Other Study ID Numbers: R34MH082156 ( U.S. NIH Grant/Contract )
DSIR 83 ATP
First Submitted: March 30, 2009
First Posted: March 31, 2009
Results First Submitted: February 15, 2017
Results First Posted: April 4, 2017
Last Update Posted: July 11, 2017
Last Verified: June 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:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Dexetimide
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
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents