Trials / Completed
CompletedNCT02709018
A Controlled Trial of Losartan in Posttraumatic Stress Disorder
Enhancing Fear Extinction Via Angiotensin Type 1 Receptor Inhibition: A Randomized Controlled Trial in Posttraumatic Stress Disorder
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 149 (actual)
- Sponsor
- University of California, San Diego · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
There are limited current treatments available for PTSD, and the only FDA-approved medications are SSRIs, which were empirically found to be somewhat helpful. Losartan provides a potentially important and exciting development in that it is readily available, safe, inexpensive (available as a generic drug), and has a neurobiological mechanism based on recent exciting discoveries, as outlined below. This proposal is designed to test, in a multisite RCT, this novel, mechanistically-determined, safe and well-tolerated, potentially powerful treatment for PTSD symptoms.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | losartan | Angiotensin receptor blocker (ARB) |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2016-07-16
- Primary completion
- 2020-02-29
- Completion
- 2020-09-29
- First posted
- 2016-03-15
- Last updated
- 2021-03-12
- Results posted
- 2021-03-12
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02709018. Inclusion in this directory is not an endorsement.