Gender
All
Age Group
18 Years to 65 Years
Accepting Healthy Volunteers
No
Key Inclusion Criteria:
- Eligible subjects are those subjects who complete study BHV4157-302 or BHV4157-303
and for whom the investigator believes open-label treatment offers an acceptable
risk-benefit profile.
- Determined by the investigator to be medically stable at the week 10 visit of
BHV4157-302 or BHV4157-303, as assessed by medical history, physical examination,
laboratory test results, and electrocardiogram testing.
- It is required that all women of child-bearing potential (WOCBP) who are sexually
active agree to use two methods of contraception for the duration of the study
Key Exclusion Criteria:
- Subjects who did not successfully complete 10 weeks of treatment in the BHV4157-302
or BHV4157-303 study.
- Acute suicidality or suicide attempt or self injurious behavior in the last 12
months.
- Patients who may have received a non-biological investigational agent in any
clinical trial within 30 days or a biological agent within 90 days prior to entry,
other than what was received in BHV4157-302 or BHV4157-303;