Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Performance Anxiety
• Age: Between 18 years - 70 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Ability and willingness to provide written informed consent
  2. Sufficiently fluent in English to participate in the trial
  3. Non-smoker, and non-nicotine user
  4. Have substantial public speaking anxiety (PSAS =60)
  5. Have a 17-item Hamilton Depression Rating Scale (HAM-D) score =18
  6. Physical examination, vital signs, electrocardiogram, and laboratory findings without clinically significant abnormalities
  7. Patients must agree to the following study restrictions:
     • Males of procreative capacity (not surgically sterile) will use an acceptable method of contraception from randomization through 1 month following the last dose of study medication
     • Females of child-bearing potential will use an acceptable method of contraception from the earlier of screening or 1 month prior to randomization through 1 month after the last dose of study medication
  8. Willing to participate in pharmacogenetics sample collection
  9. Willing and able to comply with all study requirements and restrictions, including but not limited to: Not using any of the study prohibited medications at screening or planning to use during the study period
  10. Willing to not participate in any other interventional trial for the duration of their participation

  
  

You may not be eligible for this study if the following are true:

• 1. History of suicide attempt and/or suicidal ideation with intent or specific plan or behavior consistent with a yes response to questions 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within 2 years of screening
  2. A lifetime history of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders or obsessive-compulsive disorder
  3. Posttraumatic stress disorder (PTSD) or an eating disorder within the past 6 months
  4. A history of substance or alcohol use disorder in the last 6 months or otherwise unable to commit to refraining from alcohol use during the period of study participation and/or a positive drug or alcohol screen at the Screening visit and Baseline
  5. Any concurrent psychotherapy initiated within 6 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of performance anxiety
  6. Any concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers, antipsychotics, mood stabilizers) in the last 2 months
  7. Use of concomitant medication that are strong inhibitors of CYP3A4 and CYP1A2
  8. Cognitive dysfunction including major neurocognitive disorders (e.g. dementia) and neurodevelopmental disorders that could interfere with capacity to engage in therapy
  9. Indication of impaired liver function
  10. Has a creatinine level > 1.5x ULN
  11. Current or planned pregnancy or nursing
  12. Exposure to any investigational medication, including placebo, within 60 days of screening
  13. Anyone affiliated with the site or sponsor and/or anyone who may consent under duress
  14. Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results