A Pilot Dose-Response Biomarker Study of Brexpiprazole Treatment in PTSD

This is an interventional treatment trial for Post Traumatic Stress Disorder Read More

Inclusion Criteria:

• Participants will be 18-65 years of age.
• All subjects will be evaluated by physical examination, ECG, standard blood chemistry, hematologic labs, toxicology testing, and urinalysis at baseline and end of study. Results of these studies must demonstrate a lack of clinically significant abnormalities prior to enrollment. If results are outside of the normal reference range the study physician will be consulted to assess if clinically significant.
• Subjects will need to satisfy DSM-5 criteria for PTSD and receive a CAPS-5 score of 40 or greater on testing for study enrollment.
• Subjects will need to be free of psychotropic medications or treatments that could impact results of this study as deemed by the PI for at least 1 week.
• If the subject's primary psychiatrist or treating primary care physician are providing the subject with psychotropic medications they will be notified and a discussion about tapering current psychotropic medications prior to study enrollment will occur.

Exclusion Criteria:

1. Subjects will be excluded if they have significant medical or neurologic conditions (other than mild to moderate TBI), specifically seizures, or movement disorders,
2. have substance abuse within 12 months of study enrollment, substance dependence within past three months, per DSM-5 criteria (excluding caffeine and nicotine). The absence of substance use will be determined by self-report and confirmed by the results of urine toxicology at screening.
3. Women who are pregnant, breast-feeding, or planning to become pregnant while enrolled in this study will also be excluded.
4. Subjects with a history of severe drug allergy or hypersensitivity, or known hypersensitivity to the Brexpiprazole or its ingredients.
5. The subject has a history of tardive dyskinesia.
6. The subject has clinically significant extrapyramidal symptoms (EPS) including akathisia.
7. The subject has epilepsy or a history of seizures, except for a single seizure episode (e.g., childhood febrile seizure, post traumatic, or alcohol withdrawal).

8. The subject has chronic, uncontrolled, or unstable clinically relevant medical conditions Including:

   • Uncontrolled hypertension defined as blood pressure greater than 180/90
   • Hypotension defined as a blood pressure less than 90/60
   • Moderate to severe hepatic impairment (Child-Pugh score ≥7)
   • Moderate, Severe or End-Stage Renal Impairment (CrCL <60ml/min)
   • Known CYP2DG Poor Metabolizers
   • Heart failure NYHA Class III or IV
   • Diabetes mellitus or HbA1c greater than 5.7% (which defines pre-diabetes)
   • Hypertriglyceridemia defined as triglycerides greater than 200mg/dL
   • Low white blood cell count (below lower range of normal)
   • History of leukopenia or neutropenia
   • Arrhythmia with heart rate greater than 100bpm
   • Myocardial infarction in the past 6 months
   • Cerebrovascular accident in the past 6 months
   • Recurrent syncope
   • Seizure disorder
   • Currently receiving treatment for malignancy
   • QTc interval of greater than 450ms on electrocardiogram
9. The subject has a neurodegenerative disorder (Alzheimer disease, Parkinson's disease, multiple sclerosis, Huntington disease, etc.).