Depression, Postpartum, Peripartum Depression, Postnatal Depression, Post-Natal Depression, Post-partum Depression, Postpartum Depression (PPD)
Conditions
Keywords
Postpartum Depression, PPD, Depression, LPCN 1154A, brexanolone, neuroactive steriod, GABAA
Brief summary
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
Interventions
DRUGLPCN 1154A
Oral LPCN 1154A tablets for 48 hours
DRUGPlacebo
Oral Placebo Tablets for 48 hours
Sponsors
Lipocine Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 Key
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in HAM-D17 total score compared to placebo | Baseline to Hour 60 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in HAM-D17 total score | Baseline to Hour 12 and Day 30 | 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 | Baseline to Hour 12, Hour 60 and Day 30 | 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 |
Countries
United States
Contacts
CONTACTVice President of Clinical Development
Outcome results
None listed