Post Traumatic Stress Disorder for Adults

Rexulti plus Zoloft vs Placebo

$50 per completed visit


Study Specific Details:

  • This is a 12-week, multi center, randomized, double-blind trial of brepiprazole + sertraline combination treatment in adults with PTSD. 
  • 11 visits over a 3 month study period.
  • Participant are reimbursed $50 for their time and travel at the end of each completed visit.
  • Inclusion
  • Exclusion
  • Male or Female ages 19-65.
  • The index traumatic event that led to the development of PTSD has to have occurred between 3 months and 9 years of screening visit.
  • Diagnosed with PTSD according to DSM-5 criteria, and confirmed by the MINI. 
  • Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening. 
  • Psychotherapy or any other intervention for the treatment of PTSD must be stable for a least 28 days and remain the same throughout the study period.  This includes equine therapy, yoga, mindfulness, etc.  
  • Allowed Medications: Non-stimulants, atomoxetine, and  Prazosine (Minipress) if currently being taken for an appropriate indication at a stable dose for at least 14 days prior to baseline and should be continued throughout the trial.
  • Patient does not need to fast prior screening.
  • The index traumatic event  occurred before age 16.
  • Currently experiencing trauma, have ongoing contact with their assailant/abuser, or have ongoing legal matters related to their assault/abuse. 
  • Current major depressive episode (currently symptomatic). 
  • A current or recent (w/in) 6 months prior to screening) of an anxiety disorder that has been the primary focus of psychiatric treatment including GAD, social anxiety, panic disorder, OCD, and other related disorders. 
  • Diagnosis of delirium, major neurocognitive, or other cognitive disorder, psychosis bipolar, schizophrenia, or schizoaffective disorder, eating disorder, borderline or antisocial personality disorders, or intellectual disability. 
  • A current diagnosis or history of substance or alcohol use disorder within 120 days of screening.
  • Any suicidal behavior during the past year prior to screening. 
  • Epilepsy or history of seizures , except for a single seizure episode; for instance childhood febrile seizure, a post traumatic seizure episode, or an alcohol withdrawal seizure. 
  • Moderate or severe head trauma.
  • Positive for Hepatitis B, C or HIV.
  • Individuals with hypothyroidism or hyperthyroidism (unless condition has stabilized) must be stable with medication for at least 90 days prior to baseline. 
  • Uncontrolled hypertension
  • Diabetic - may be eligible if the condition is stable and well controlled as determined by study team. 
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