The Montgomery Asberg Depression rating scale is a 10-item scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The total score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.

Modified Intent To Treat population - all subjects who are randomized to receive treatment, receive at least one dose of study drug, and have a Baseline and at least one post-dose efficacy assessment.

The CGI-S is a 7-point scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. A score of 1 represents "normal" and 7 represents "most extremely ill".

Modified Intent To Treat population - all subjects who are randomized to receive treatment, receive at least one dose of study drug, and have a Baseline and at least one post-dose efficacy assessment.

The 17-item Hamilton Depression rating scale is used to assess the severity of depression. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=No difficulty/absent and 4=most severe. The total score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression.

Modified Intent To Treat population - all subjects who are randomized to receive treatment, receive at least one dose of study drug, and have a Baseline and at least one post-dose efficacy assessment.

The Sheehan Disability Scale is a 3-part scale that measures the degree of disruption on work, social, and family life using an 11-point scale where 0 represents "no disruption" and 10 represents "extreme disruption". Each item (work, social, and family life) can have a score of 0-10. A total global functioning impairment score can be utilized by summing the scores from work, social, and family life scales for a value range from 0 to 30, where a higher score represents a worse outcome, i.e., more disruption on work, social, and family life. In addition to the 11-point scale, participants are asked to indicate the number of days in the past week that were "lost" and numbers of days that were "unproductive". The results of these questions have a range from 0 to 7 and are not included in the overall scale total.

Modified Intent To Treat population - all subjects who are randomized to receive treatment, receive at least one dose of study drug, and have a Baseline and at least one post-dose efficacy assessment.

The Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR), is a 16 item self-reported scale where each item has a 4-point scale where 0 represents least impact scores while 3 represents greatest impact scores. Some questions are linked such that the highest score in a group of questions is entered once. For example, there are 4 questions related to sleep and the highest score on any of the 4 sleep items is entered once. The total score ranges from 0 to 27 where a higher score indicates more depression.

Modified Intent To Treat population - all subjects who are randomized to receive treatment, receive at least one dose of study drug, and have a Baseline and at least one post-dose efficacy assessment.

The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item satisfaction scale where each item has a 5-point scale. A score of 1 represents "very poor satisfaction", while a score of 5 represents "very good satisfaction". Only the first 14 items are summed for a total score that ranges from 14 to 70, where a lower score represents a worse outcome.

Modified Intent To Treat population - all subjects who are randomized to receive treatment, receive at least one dose of study drug, and have a Baseline and at least one post-dose efficacy assessment.

The Montgomery Asberg Depression rating scale is a 10-item scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The total score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.

Modified Intent To Treat population - all subjects who are randomized to receive treatment, receive at least one dose of study drug, and have a Baseline and at least one post-dose efficacy assessment.

The CGI-S is a 7-point scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. A score of 1 represents "normal" and 7 represents "most extremely ill".

Modified Intent To Treat population - all subjects who are randomized to receive treatment, receive at least one dose of study drug, and have a Baseline and at least one post-dose efficacy assessment.

The Montgomery Asberg Depression rating scale is a 10-item scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The total score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.

Modified Intent To Treat population - all subjects who are randomized to receive treatment, receive at least one dose of study drug, and have a Baseline and at least one post-dose efficacy assessment.

The CGI-S is a 7-point scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. A score of 1 represents "normal" and 7 represents "most extremely ill".

Modified Intent To Treat population - all subjects who are randomized to receive treatment, receive at least one dose of study drug, and have a Baseline and at least one post-dose efficacy assessment.