Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Definium Therapeutics US, Inc.
The study will enroll approximately 200 male and female subjects 18 years to \< 75 years of age who meet DSM-5 criteria for GAD and have a minimum HAM-A Total Score of 20. Subjects on contraindicated concomitant medications, supplements or other therapeutics at Screening (Visit 1) will undergo a medication taper prior to advancing to Baseline (Visit 2).
Age
18–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Bodyweight of ≥ 50 kg
Body mass index \[BMI\] ≥ 18 to ≤ 38 mg/kg2
Diagnosis of DSM-5 generalized anxiety disorder
Acceptable overall medical condition to be safely enrolled into and to complete the study
Ability to swallow capsules
Ability to provide informed consent
You may not be if
Women of childbearing potential (WOCBP) (i.e., physiologically capable of becoming pregnant) who are unwilling or unable to use a highly effective method of contraception for the duration of the study, OR Men physiologically capable of fathering a child who are sexually active with WOCBP but are unwilling or unable to use barrier contraception (e.g., condom with or without spermicidal cream or jelly) for the duration of the study
Women who are currently pregnant or breastfeeding or plan to become pregnant or breastfeed during the study
Men who plan to donate sperm during the study
Prior history (lifetime diagnosis) with a lifetime diagnosis of schizophrenia spectrum, or other psychotic disorders or bipolar disorder
Has a significant risk of suicide attempt based upon medical history or has active suicidal ideation
Unwillingness or inability to discontinue prohibited concomitant medications, supplements or other therapeutics (prescription or over-the-counter)
