Trial Outcomes & Findings for Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder (NCT NCT01271244)

Results Overview

Heart rate variability is the standard deviation of successive R-to-R intervals, or variability in time between successive heart beats. Spectral power in the high frequency (HF: 0.15-0.5 Hz) band reflects parasympathetic input, or cardiac vagal function. A natural log (ln) transformation was applied to heart rate variability data to derive the outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

12 Weeks

Results posted on

2019-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	PTSD Depression Group Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks	Major Depression Group Veteran with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks
Overall Study STARTED	18	8
Overall Study COMPLETED	11	5
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PTSD Depression Group n=11 Participants Veterans with PTSD and Depression will receive Escitalopram: 10-20mg daily for 12 weeks	Major Depression Group n=5 Participants Veterans with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks	Total n=16 Participants Total of all reporting groups
Age, Continuous	28.3 YEARS STANDARD_DEVIATION 2.4 • n=5 Participants	30 YEARS STANDARD_DEVIATION 4.1 • n=7 Participants	29 YEARS STANDARD_DEVIATION 1.41 • n=5 Participants
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	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	5 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Weeks

Population: Due to the small number of subjects in the major depression group, results were not analyzed for this group.

Heart rate variability is the standard deviation of successive R-to-R intervals, or variability in time between successive heart beats. Spectral power in the high frequency (HF: 0.15-0.5 Hz) band reflects parasympathetic input, or cardiac vagal function. A natural log (ln) transformation was applied to heart rate variability data to derive the outcome measure.

Outcome measures

Outcome measures
Measure	PTSD Depression Group n=11 Participants Veterans with PTSD and depression receive Escitalopram: 10-20mg daily for 12 weeks	Major Depression Group Veterans with major depression receive Escitalopram: 10-20mg daily for 12 weeks
High Frequency Heart Rate Variability Pre-treatment	6.31 ln(msec) Standard Deviation 1.16	—
High Frequency Heart Rate Variability Post-treatment	5.48 ln(msec) Standard Deviation 0.67	—

PRIMARY outcome

Timeframe: 12 weeks

Population: Due to the small number of subjects in the major depression group, results were not analyzed for this group.

QT variability index (QTvi) is a measure of QT variability normalized to heart rate variability. Increased QTvi has been associated with increased sympathetic activity. QTvi was calculated using Berger's formula as the log ratio of QT variability normalized by the squared mean QT interval divided by heart rate variability normalized by the squared mean heart rate. QTvi is normally expressed as a negative value, and a less negative QTvi may reflect increased QT variability or reduced heart rate variability.

Outcome measures

Outcome measures
Measure	PTSD Depression Group n=11 Participants Veterans with PTSD and depression receive Escitalopram: 10-20mg daily for 12 weeks	Major Depression Group Veterans with major depression receive Escitalopram: 10-20mg daily for 12 weeks
QT Interval Variability Pre-treatment	-1.82 log ratio Standard Deviation 0.43	—
QT Interval Variability Post-treatment	-1.32 log ratio Standard Deviation 0.67	—

Adverse Events

PTSD Depression Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Major Depression Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PTSD Depression Group n=18 participants at risk Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks	Major Depression Group n=8 participants at risk Veterans with Major Depression only receive Escitalopram: 10-20mg daily for 12 weeks
Psychiatric disorders Suicidal Ideation	0.00% 0/18 • 12 weeks	12.5% 1/8 • 12 weeks

Other adverse events

Adverse event data not reported

Additional Information

SRIRAM RAMASWAMY MD

VA NEBRASKA WESTERN IOWA VA HEALTHCARE

Phone: 4029954712

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place