The purpose of this research study is to test the study drug, LPCN 1154A, as a possible treatment for postpartum depression (PPD). The trial aims to determine:
* If LPCN 1154A reduces depressive symptoms in subjects with severe PPD * How well LPCN 1154A is tolerated and what side effects it may cause
Are female between 15 and 45 years of age, inclusive;
Have had a depressive episode that began no earlier than second trimester and no later than the first 4 weeks following delivery
Are < 18 months postpartum at Screening
Hamilton Depression Rating Scale (HAM-D) 17-item score indicative of severe depression
Have a history of bipolar disorder, schizophrenia or schizoaffective disorder
Are currently experiencing active psychosis per Investigator assessment
Have a history of suicidal behavior associated with the current depressive episode
Have a history of seizure within six months of Screening
Parallel
LPCN 1154A
DrugOral LPCN 1154A tablets for 48 hours
Placebo
DrugOral Placebo Tablets for 48 hours
Change from baseline in HAM-D17 total score compared to placebo
The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) contains 17 individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia (initial, middle, and late), work and activities, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, genital symptoms, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Change from baseline in HAM-D17 total score
The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) contains 17 individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia (initial, middle, and late), work and activities, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, genital symptoms, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Change from baseline Clinical Global Impression of Severity (CGI-S) scale positive response
The CGI-S scale is a 7-point scale that requires the Investigator to assess the severity of a patient's illness. Scores range from 1 -normal, not at all ill to 7 - among the most extremely ill patients
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