Phase 4
N=15
Preventing Depression in People Receiving Mechanical Ventilation in an Intensive Care Unit
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00872027 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Recruitment Feasibility, Defined as the Number of Participants Recruited and Administered a Medication Dose Within 48 Hours of Mechanical Ventilation — 7; 8 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Escitalopram (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Feasibility, Defined as the Number of Participants Recruited and Administered a Medication Dose Within 48 Hours of Mechanical Ventilation |
7; 8 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT00872027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.