Trial Outcomes & Findings for Preventing Depression in People Receiving Mechanical Ventilation in an Intensive Care Unit (NCT NCT00872027)

NCT ID: NCT00872027

Last Updated: 2017-12-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: Measured within 2 days of participant recruitment
• Results posted on: 2017-12-19

Participant Flow

Participant milestones

Measure	Participants Will Receive 8 Weeks of Escitalopram Treatment. Participants will receive 8 weeks of escitalopram treatment. 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	Participants Will Receive 8 Weeks of Placebo Pills. Participants will receive 8 weeks of placebo pills. Placebo: Placebo pills for 8 weeks
Overall Study STARTED	7	8
Overall Study COMPLETED	7	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Participants Will Receive 8 Weeks of Escitalopram Treatment. n=7 Participants Participants will receive 8 weeks of escitalopram treatment. 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	Participants Will Receive 8 Weeks of Placebo Pills. n=8 Participants Participants will receive 8 weeks of placebo pills. Placebo: Placebo pills for 8 weeks	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured within 2 days of participant recruitment

Outcome measures

Measure	Participants Will Receive 8 Weeks of Escitalopram Treatment. n=7 Participants Participants will receive 8 weeks of escitalopram treatment. 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	Participants Will Receive 8 Weeks of Placebo Pills. n=8 Participants Participants will receive 8 weeks of placebo pills. Placebo: Placebo pills for 8 weeks
Recruitment Feasibility, Defined as the Number of Participants Recruited and Administered a Medication Dose Within 48 Hours of Mechanical Ventilation	7 participants	8 participants

Adverse Events

Participants Will Receive 8 Weeks of Escitalopram Treatment.

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Participants Will Receive 8 Weeks of Placebo Pills.

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Participants Will Receive 8 Weeks of Escitalopram Treatment. n=7 participants at risk Participants will receive 8 weeks of escitalopram treatment. 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	Participants Will Receive 8 Weeks of Placebo Pills. n=8 participants at risk Participants will receive 8 weeks of placebo pills. Placebo: Placebo pills for 8 weeks
Gastrointestinal disorders GI	71.4% 5/7 • Number of events 5 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.	87.5% 7/8 • Number of events 7 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.
Cardiac disorders Heart	14.3% 1/7 • Number of events 4 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.	50.0% 4/8 • Number of events 4 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.
Skin and subcutaneous tissue disorders Skin	57.1% 4/7 • Number of events 5 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.	50.0% 4/8 • Number of events 4 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.
Nervous system disorders Nervous Sytem	14.3% 1/7 • Number of events 3 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.	25.0% 2/8 • Number of events 3 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.
Ear and labyrinth disorders Eye/Ear	28.6% 2/7 • Number of events 2 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.	0.00% 0/8 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.
Renal and urinary disorders Genital/Urinary	28.6% 2/7 • Number of events 4 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.	50.0% 4/8 • Number of events 4 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.
General disorders Sleep	28.6% 2/7 • Number of events 5 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.	37.5% 3/8 • Number of events 4 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.
General disorders Other	42.9% 3/7 • Number of events 5 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.	62.5% 5/8 • Number of events 5 • These were collected over a 48 hour period. Adverse event collection was done by body system and not specific event.

Additional Information

Craig Weinert MD

University of Minnesota

Phone: 612-624-0999

Email: weine006@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place