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

NCT ID: NCT00872027

Last Updated: 2017-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-07-31

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.

Conditions

Depression

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

Participants will receive 8 weeks of escitalopram treatment.

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: 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

2

Participants will receive 8 weeks of placebo pills.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo pills for 8 weeks

Interventions

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

Intervention Type: DRUG

Placebo

Placebo pills for 8 weeks

Intervention Type: DRUG

Other Intervention Names

Lexapro

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Weinert, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

R34MH082156

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 83 ATP

Identifier Type: -

Identifier Source: secondary_id

R34MH082156

Identifier Type: NIH

Identifier Source: org_study_id

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