Biomarker Changes and Anxiolytic Effects-Phase 2

Inclusion Criteria

• Adults ages 18-50 who meet Diagnostic Statistical Manual (DSM)-5 criteria for GAD as the primary psychiatric diagnosis
• No more than one failed therapeutic trial of an FDA approved medication for the treatment of GAD
• Score of>14 on the Hamilton Anxiety Rating Scale at both screening and baseline
• At least a 4 (moderate) on the Clinical Global Impressions Severity Scale at both screening and baseline
• Females of potential childbearing status must use adequate contraceptive precautions.

Exclusion Criteria

• Unwilling/unable/unsafe to stop psychotropic medications (if on any) for the duration of the study
• Inability to refrain from acetaminophen, alcohol or other potentially hepatotoxic substances
• History of liver disease or current liver disease or clinically significant elevation in serum liver chemistries
• Unstable medical or neurological condition
• Positive urine drug screen for substances of abuse
• Active substance abuse/dependence
• Lifetime history of a psychotic disorder, bipolar disorder, PTSD or Obsessive Compulsive Disorder
• Any significant risk for self-harm or suicidality as determined by the principal investigator or suicide attempt within the last 6 months
• Psychotherapy newly instituted during the 6 weeks leading up to enrollment in the study. Subjects established in psychotherapy without change during the course of the study may participate
• Montgomery-Asberg Depression Rating Scale (MADRS) > 17 (moderate or severe depressive symptoms)