Depression, Postpartum, Depression, Post-Partum, Peripartum Depression, Postnatal Depression, Post-Natal Depression, Postpartum Depression (PPD)
Conditions
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 * If LPCN 1154A reduces anxiety symptoms in subjects with severe PPD
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 third trimester and later than the first 4 week following delivery * Are \< 12 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 within 1 year * Have a history of seizure within 6 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 interests, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, sexual interest, 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 |
|---|---|---|
| Incidence, severity, and causality of AEs and SAEs | upto Day 30 | Adverse events (AEs) and Serious Adverse Events (SAEs) |
| Change from baseline in HAM-D17 total score | Baseline at Hours 12, and 36, Day 7 and Day 30 | The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) evaluates mood, suicide, work and interests, retardation, agitation, gastrointestinal symptoms, somatic symptoms, hypochondriasis, body weight and insight The total score ranges from 0 to 52, with higher scores indicating more severe depression. |
| HAM-D17 response | Baseline to Hours 12, and 36, 60, Day 7 and Day 30 | Defined as having a 50% or greater reduction from baseline in HAM-D17 total score. The total score ranges from 0 to 52, with higher scores indicating more severe depression. |
| HAM-D17 remission | Hours 12, and 36, 60, Day 7 and Day 30 | Defined as having a HAM-D17 total score ≤7. The total score ranges from 0 to 52, with higher scores indicating more severe depression. |
| Patient Global Impression - Change (PGI-C) scale positive response | Hours 12, and 36, 60, Day 7 and Day 30 | The PGI-C scale is a 7-point scale that ranges from "1-very much better" to "7-very much worse" that allows participants to self- report their perception of improvement or decline of overall symptoms since starting treatment. |
| Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score | Baseline to Hour 60 and Day 30 | The MADRS is a 10-item assessment that evaluates mood/thoughts, sleep, appetite, tension, concentration The total score ranges from 0 to 60, with higher scores indicating more severe depression. |
| Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score | Baseline to Hours 12, 36, 60 Day 7 and Day 30 | The HAM-A is a 14-item assessment that evaluates mood, tension, fear, memory/concentration, sleep, and physical symptoms affecting somatic, sensory, respiratory, cardiovascular, gastrointestinal, genitourinary, and autoimmune systems as it relates to anxiety. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety. |
Countries
United States
Outcome results
None listed