Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression

Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score

The CGI-S is a clinician-rated scale to assess disease severity. The scale is scored on 8-point scale (0 \[not assessed\] to 7 \[severe\]). A higher score represents a higher severity illness.

Time frame: Baseline to Week 6

Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 6

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.

Time frame: Baseline to Week 6

Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1

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).

Time frame: Baseline to Week 1

Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 1

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.