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

NCT00872027 | Completed Phase 4 Results

• 2 other identifiers: R34MH082156DSIR 83 ATP
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression

Keywords

Critical Illness; Intensive Care Unit; Acute Respiratory Failure; Prolonged Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Participants will receive 8 weeks of escitalopram treatment.

Drug: Escitalopram

2

PLACEBO COMPARATOR

Participants will receive 8 weeks of placebo pills.

Drug: Placebo

Interventions

Escitalopram DRUG

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

Also known as: Lexapro

1

Placebo DRUG

Placebo pills for 8 weeks

2

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Depression; Critical Illness

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Craig Weinert MD
• Organization: University of Minnesota

weine006@umn.edu

612-624-0999

Study Officials

• Craig Weinert, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 19, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-11

Locations

US (1)