A Controlled Trial of Losartan in Posttraumatic Stress Disorder

Completed · Not applicable · Has a placebo group

Conditions studied: Posttraumatic Stress Disorder

In brief

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.

Key facts

Study ID: NCT02709018
Run by: University of California, San Diego
People needed: 149
Starts: 2016-07-16
Expected to finish: 2020-09-29
Last updated by the study team: 2021-03-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject must be a man or woman between 18 and 70 years of age, inclusive.
Subjects must have a primary DSM-5 diagnosis of Posttraumatic Stress Disorder.
Subjects must have a Clinical Administered PTSD Scale for PTSD (CAPS-5) ≥ 25 persistent at Screening for at least 3 months duration.
Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
Subject must be willing and able to fill out self-administered questionnaires.
Subject must be able to be compliant with self-administration of medication.
Subject must be able to swallow the study medication whole with aid of water.
Subject must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

You may not qualify if…

Subjects who have current or imminent risk of suicide as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) at each study visit.
Subject with active psychosis.
Subject has a history of moderate or severe drug or alcohol use disorder according to DSM-5 criteria within 3 months before screening.
Subject has a history of allergy to losartan or other angiotensin receptor blockers (ARBs).
Subject has a medical illness likely to result in imminent hospitalization or for which treatments are contraindicated based on lab results, medical history and physical exam.
Subject has serious cognitive impairment felt likely to interfere with the ability to participate meaningfully in the study. Participants with mild to moderate traumatic brain injury (TBI) will not be excluded from the study. Only those who evidence significant cognitive impairment at Screening (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment) will be excluded.
Concurrent ACE Inhibitors or Angiotensin Receptor Blockers or Prazosin; patients on other antihypertensives may be enrolled if, after consultation with their prescribing physician, it is determined that the addition of losartan would not be contraindicated.
Concurrent antidepressants or antipsychotics. Subjects, who have elected, in consultation with their health care provider, to discontinue any antidepressants or antipsychotics, must be off the medications for a minimum of 2 weeks prior to study randomization. Stable bedtime doses of sleep agents (e.g., trazodone ≤ 200mg; eszopiclone; zolpidem; lorazepam) will be allowed as long as the dose has been stable for at least 2 weeks prior to study randomization. Benzodiazepines taken for other than sleep are not permitted.
Subject is a woman who is pregnant, or breast-feeding, or planning to become pregnant.
Subject is unable to comply with the study-specific requirements
Subjects with abnormal liver, renal or EKG findings as determined by physician.
Subject exhibits clinically-significant hypertension as determined by medical evaluation and/or BP > 190/100.
Systolic Blood Pressure (SBP) < 90mmHg.
Liver function Tests (LFT's) > 2 times the upper limit of normal.
Patients with Chronic Kidney Disease 4, as determined by history, baseline labs (including eGFR < 45ml/minute) and evaluation by a physician will be excluded

Where it is running

University of California, San Diego — La Jolla, California, United States
George Washington University — Washington D.C., District of Columbia, United States
Walter Reed National Military Medical Center — Bethesda, Maryland, United States
McLean Hospital — Belmont, Massachusetts, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
New York University Langone Health — New York, New York, United States

Full record on ClinicalTrials.gov

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