A Controlled Trial of Losartan in Posttraumatic Stress Disorder

Exclusion Criteria

• •1. Subjects who have current or imminent risk of suicide as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) at each study visit.
• •2. Subject with active psychosis.
• •3. Subject has a history of moderate or severe drug or alcohol use disorder according to DSM-5 criteria within 3 months before screening.
• •4. Subject has a history of allergy to losartan or other angiotensin receptor blockers (ARBs).
• •5. 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.
• •6. 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.
• •7. 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.
• •8. 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.
• •9. Subject is a woman who is pregnant, or breast-feeding, or planning to become pregnant.
• •10. Subject is unable to comply with the study-specific requirements
• •11. Subjects with abnormal liver, renal or EKG findings as determined by physician.
• •12. Subject exhibits clinically-significant hypertension as determined by medical evaluation and/or BP \> 190/100.
• •13. Systolic Blood Pressure (SBP) \< 90mmHg.
• •14. Liver function Tests (LFT's) \> 2 times the upper limit of normal.
• •15. Patients with Chronic Kidney Disease 4, as determined by history, baseline labs (including eGFR \< 45ml/minute) and evaluation by a physician will be excluded