NCT02709018: LOSe-PTSD

A Controlled Trial of Losartan in Posttraumatic Stress Disorder

Completed NA Results posted Last updated 12 March 2021

What this trial tests

NA trial testing losartan in Posttraumatic Stress Disorder in 149 participants. Completed in 29 September 2020.

Timeline

16 July 2016

Primary endpoint
29 February 2020

29 September 2020

Quick facts

Lead sponsor	University of California, San Diego
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	149
Start date	16 July 2016
Primary completion	29 February 2020
Estimated completion	29 September 2020
Sites	6 locations across United States

Drugs / interventions tested

• losartan (losartan) — full drug profile →
• Placebo

Conditions studied

• Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →

Sponsor

University of California, San Diego

Who can join

Adults 18 to 70, any sex, with Posttraumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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. Primary · 10 weeks

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.

Group	Value	95% CI
Losartan	-15.96	-18.86 – -13.06
Placebo	-16.89	-19.81 – -13.97

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. Secondary · 10 weeks

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.

Group	Value	95% CI
CC Homozygotes on Losartan	16.7	± 10.1
T Carriers on Losartan	15.8	± 13.1

Adverse events — posted to ClinicalTrials.gov

Time frame: 10 Weeks (Study Duration). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Losartan

Serious: 2/75 (3%)

Deaths: 0/75

Placebo

Serious: 1/74 (1%)

Deaths: 0/74

Serious adverse events (3 terms)

Reaction	System	Losartan	Placebo
Neurosyphilis	Nervous system disorders	—	—
Cataplexy	Nervous system disorders	—	—
Gallbladder Pain	Gastrointestinal disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Losartan	Placebo
headache	Nervous system disorders	—	—
Lightheadedness	Nervous system disorders	—	—
Insomnia	Nervous system disorders	—	—

Most-reported serious reactions: Neurosyphilis, Cataplexy, Gallbladder Pain.

Data from ClinicalTrials.gov NCT02709018 adverse events section.

Sponsor's own description

This study is being conducted to determine if losartan, an angiotensin receptor blocker (ARB), is safe and effective in the treatment of posttraumatic stress disorder (PTSD) symptoms. The study is also intended to determine if certain genetic markers are useful in predicting PTSD symptom reduction with losartan. Approximately 160 subjects with chronic PTSD ages 18-65 will participate in this study across five sites. Subjects will be assigned by chance to take either flexibly dosed losartan (up to a maximum dosage of 100 mg) or placebo (which resembles the study drug but has no active ingredients), once a day for 10 weeks. Furthermore, it is hypothesized that CC homozygotes for rs4311 SNP in the ACE gene will have a superior response to losartan on PTSD symptoms compared to T carriers.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmacotherapy for post traumatic stress disorder (PTSD).
   Williams T, Phillips NJ, Stein DJ, Ipser JC. · · 2022 · cited 62× · PMID 35234292 · DOI 10.1002/14651858.cd002795.pub3
2. A decennial review of psychotraumatology: what did we learn and where are we going?
   Olff M, Amstadter A, Armour C, Birkeland MS, et al · · 2019 · cited 52× · PMID 31897268 · DOI 10.1080/20008198.2019.1672948
3. Randomized, Placebo-Controlled Trial of the Angiotensin Receptor Antagonist Losartan for Posttraumatic Stress Disorder.
   Stein MB, Jain S, Simon NM, West JC, et al · · 2021 · cited 26× · PMID 34275593 · DOI 10.1016/j.biopsych.2021.05.012
4. Pharmacotherapy of anxiety disorders in the 21st century: A call for novel approaches.
   Bui E, King F, Melaragno A. · · 2019 · cited 7× · PMID 31922087 · DOI 10.1136/gpsych-2019-100136