Trial Outcomes & Findings for A Controlled Trial of Losartan in Posttraumatic Stress Disorder (NCT NCT02709018)

Last Updated: 2021-03-12

Results Overview

Clinician-Administered PTSD Scale for DSM-5 also known as CAPS-5 is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to, make current (past month) diagnosis of PTSD, make a lifetime diagnosis of PTSD and assess PTSD symptoms over the past week. The CAPS-5 as used here has 20 items, each scored 0-4, to yield a score with a possible range of 0-80. Higher scores mean worse outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

149 participants

Primary outcome timeframe

10 weeks

Results posted on

2021-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	Losartan Losartan flexibly dosed from 25-100 mg per day over 10 weeks losartan: Angiotensin receptor blocker (ARB)	Placebo Placebo flexibly dosed from 25-100 mg per day over 10 weeks Placebo: Placebo
Overall Study STARTED	75	74
Overall Study COMPLETED	59	58
Overall Study NOT COMPLETED	16	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Controlled Trial of Losartan in Posttraumatic Stress Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Losartan n=75 Participants Losartan flexibly dosed from 25-100 mg per day over 10 weeks losartan: Angiotensin receptor blocker (ARB)	Placebo n=74 Participants Placebo flexibly dosed from 25-100 mg per day over 10 weeks Placebo: Placebo	Total n=149 Participants Total of all reporting groups
Age, Continuous	36.4 years STANDARD_DEVIATION 12.3 • n=5 Participants	35.5 years STANDARD_DEVIATION 12.6 • n=7 Participants	36.0 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	54 Participants n=7 Participants	97 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	20 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	44 Participants n=7 Participants	94 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
CAPS-5 Total	33.5 units on a scale STANDARD_DEVIATION 10.3 • n=5 Participants	34.2 units on a scale STANDARD_DEVIATION 10.0 • n=7 Participants	33.8 units on a scale STANDARD_DEVIATION 10.2 • n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: Modified Intent to Treat (mITT) Population

Outcome measures

Outcome measures
Measure	Losartan n=58 Participants Losartan flexibly dosed from 25-100 mg per day over 10 weeks losartan: Angiotensin receptor blocker (ARB)	Placebo n=58 Participants Placebo flexibly dosed from 25-100 mg per day over 10 weeks Placebo: Placebo
The Primary Outcome for This Study is Mean Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Over the Treatment Period of 10 Weeks Between the Losartan Arm and the Placebo Arm.	-15.96 score on a scale Interval -18.86 to -13.06	-16.89 score on a scale Interval -19.81 to -13.97

SECONDARY outcome

Timeframe: 10 weeks

Population: Subjects on Losartan Arm

The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) as used here has 20 items, each scored 0-4, to yield a score with a possible range of 0-80. Higher scores mean worse outcome.

Outcome measures

Outcome measures
Measure	Losartan n=11 Participants Losartan flexibly dosed from 25-100 mg per day over 10 weeks losartan: Angiotensin receptor blocker (ARB)	Placebo n=40 Participants Placebo flexibly dosed from 25-100 mg per day over 10 weeks Placebo: Placebo
Change in CAPS-5 Associated With CC Homozygosity for rs4311 SNP in the Angiotensin Converting Enzyme Gene (ACE) Compared to T Carriers, Among Subjects Randomized to Losartan.	16.7 score on a scale Standard Deviation 10.1	15.8 score on a scale Standard Deviation 13.1

Adverse Events

Losartan

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Losartan n=75 participants at risk Losartan flexibly dosed from 25-100 mg per day over 10 weeks losartan: Angiotensin receptor blocker (ARB)	Placebo n=74 participants at risk Placebo flexibly dosed from 25-100 mg per day over 10 weeks Placebo: Placebo
Nervous system disorders Neurosyphilis	0.00% 0/75 • 10 Weeks (Study Duration)	1.4% 1/74 • Number of events 1 • 10 Weeks (Study Duration)
Nervous system disorders Cataplexy	1.3% 1/75 • Number of events 1 • 10 Weeks (Study Duration)	0.00% 0/74 • 10 Weeks (Study Duration)
Gastrointestinal disorders Gallbladder Pain	1.3% 1/75 • Number of events 1 • 10 Weeks (Study Duration)	0.00% 0/74 • 10 Weeks (Study Duration)

Other adverse events

Other adverse events
Measure	Losartan n=75 participants at risk Losartan flexibly dosed from 25-100 mg per day over 10 weeks losartan: Angiotensin receptor blocker (ARB)	Placebo n=74 participants at risk Placebo flexibly dosed from 25-100 mg per day over 10 weeks Placebo: Placebo
Nervous system disorders Lightheadedness	10.7% 8/75 • Number of events 13 • 10 Weeks (Study Duration)	9.5% 7/74 • Number of events 9 • 10 Weeks (Study Duration)
Nervous system disorders Insomnia	5.3% 4/75 • Number of events 4 • 10 Weeks (Study Duration)	6.8% 5/74 • Number of events 5 • 10 Weeks (Study Duration)
Nervous system disorders headache	21.3% 16/75 • Number of events 24 • 10 Weeks (Study Duration)	18.9% 14/74 • Number of events 21 • 10 Weeks (Study Duration)

Additional Information

Murray B. Stein MD, MPH

University of California San Diego

Phone: 858-534-6451

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place