Preventing Depression in People Receiving Mechanical Ventilation in an Intensive Care Unit
Primary Purpose
Depression
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring Critical Illness, Intensive Care Unit, Acute Respiratory Failure, Prolonged Mechanical Ventilation
Eligibility 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
Sites / Locations
- University of Minnesota Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Participants will receive 8 weeks of escitalopram treatment.
Participants will receive 8 weeks of placebo pills.
Outcomes
Primary Outcome Measures
Recruitment Feasibility, Defined as the Number of Participants Recruited and Administered a Medication Dose Within 48 Hours of Mechanical Ventilation
Secondary Outcome Measures
Full Information
NCT ID
NCT00872027
First Posted
March 30, 2009
Last Updated
November 21, 2017
Sponsor
University of Minnesota
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00872027
Brief Title
Preventing Depression in People Receiving Mechanical Ventilation in an Intensive Care Unit
Official Title
Feasibility Study to Prevent Post-ICU Depression
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Critical Illness, Intensive Care Unit, Acute Respiratory Failure, Prolonged Mechanical Ventilation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive 8 weeks of escitalopram treatment.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Participants will receive 8 weeks of placebo pills.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pills for 8 weeks
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Weinert, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Preventing Depression in People Receiving Mechanical Ventilation in an Intensive Care Unit
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