The MADRS is a clinician- rated scale to assess depressive symptoms which consists of 10 items. Each item is scored on 7-point scale (0 [absence of symptoms] to 6 [severe]). A higher score represents a higher severity of the level of depression (total scores range from 0 to 60).

The SHAPS is a subject self- administered scale to measure hedonic capacity which consists of 14 items (total scores range from 0 to 14). Each item has a set of 4 possible responses (Strongly or Definitely Agree, Agree, Disagree and Strongly Disagree). A total score is derived by summing the responses to each item. A higher score represents a higher level of anhedonia.

The Q-LES-Q-SF is a participant self-administered scale to assess the degree of enjoyment and satisfaction experienced in various areas of daily functioning. The form consists of 16 items. Each item is scored on 5-point scale. A higher score represents a higher level of satisfaction and enjoyment (total scores range from 14 to 70).

Safety and tolerability of BHV-7000 as assessed by frequency of unique subjects with SAEs; AEs leading to discontinuation; AEs judged to be related to study medication

To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.