Post Traumatic Stress Disorder for Adults

Rexulti plus Zoloft vs Placebo

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.

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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