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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00872027
First received: March 30, 2009
Last updated: April 3, 2009
Last verified: April 2009
  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: Double Blind (Subject, Caregiver, 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 National Institute of Mental Health (NIMH):

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of planned study doses actually administered to participants [ Time Frame: Measured after 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of completed interviews, excluding follow-ups [ Time Frame: Measured after 8 weeks ] [ Designated as safety issue: No ]
  • Participant reconsent rate [ Time Frame: Measured after 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants enrolled compared to all eligible participants [ Time Frame: Measured 1 day after recruitment ] [ Designated as safety issue: No ]
  • Rate, timing, and tolerability of medication dose escalation to 20 mg [ Time Frame: Measured after 5 weeks ] [ Designated as safety issue: Yes ]
  • Rate of off-protocol antidepressant use [ Time Frame: Measured after 8 weeks ] [ Designated as safety issue: Yes ]
  • Success of experimental medication blinding [ Time Frame: Measured after 8 weeks ] [ Designated as safety issue: No ]
  • Depression severity, measured by Center for Epidemiological Studies Depression Scale (CES-D), between the two arms [ Time Frame: Measured after 8 weeks ] [ Designated as safety issue: No ]
  • Depression severity, measured by the 17-item Hamilton Depression Scale (HAM-D17) [ Time Frame: Measured after 8 weeks ] [ Designated as safety issue: No ]
  • Depression severity, measured by Montgomery Åsberg Depression Rating Scale (MADRS) [ Time Frame: Measured after 8 weeks ] [ Designated as safety issue: No ]
  • Rate of suicide attempts and suicidal ideation [ Time Frame: Measured after 8 weeks ] [ Designated as safety issue: Yes ]
  • Rate and severity of medication withdrawal symptoms [ Time Frame: Measured after 9 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of major depressive episodes and incidences of major depressive disorder, measured by the Structured Clinical Interview for DSM-IV (SCID) [ Time Frame: Measured after 8 weeks ] [ Designated as safety issue: No ]
  • Quality of life, measured by the 12-item Short Form Health Survey (SF-12) [ Time Frame: Measured after 8 weeks ] [ Designated as safety issue: No ]
  • Rates of adverse events, serious adverse events, and deaths after the end of treatment [ Time Frame: Measured after 12 weeks ] [ Designated as safety issue: Yes ]
  • Participant burden, defined as the time taken for completion of the study questionnaires [ Time Frame: Measured after 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: July 2011
Estimated 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

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872027

Contacts
Contact: Craig Weinert, MD 612-624-0999 weine006@umn.edu

Locations
United States, Minnesota
University of Minnesota Medical Center Active, not recruiting
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Investigators
Principal Investigator: Craig Weinert, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Craig Weinert, MD, University of Minnesota
ClinicalTrials.gov Identifier: NCT00872027     History of Changes
Other Study ID Numbers: R34 MH082156, DSIR 83 ATP
Study First Received: March 30, 2009
Last Updated: April 3, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Critical Illness
Intensive Care Unit
Acute Respiratory Failure
Prolonged Mechanical Ventilation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 14, 2014