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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Oral LPCN 1154A tablets for 48 hours
Oral Placebo Tablets for 48 hours
Advanced Research Center
Anahiem, California, United States
Alliance Research Institute
Canoga Park, California, United States
MedOne Clinical Research, LLC
Miami, Florida, United States
D&H National Research Centers
Miami, Florida, United States
Meridian International Research
Miami Gardens, Florida, United States
Atlanta Behavioral Research
Atlanta, Georgia, United States
CenExel Research Center
Decatur, Georgia, United States
CenExel Research Center
Savannah, Georgia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Cypress Medical Research Center, LLC
Kansas City, Kansas, United States
...and 8 more locations
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 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.
Time frame: Baseline to Hour 60
Incidence, severity, and causality of AEs and SAEs
Adverse events (AEs) and Serious Adverse Events (SAEs)
Time frame: upto Day 30
Change from baseline in HAM-D17 total score
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.
Time frame: Baseline at Hours 12, and 36, Day 7 and Day 30
HAM-D17 response
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.
Time frame: Baseline to Hours 12, and 36, 60, Day 7 and Day 30
HAM-D17 remission
Defined as having a HAM-D17 total score ≤7. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Time frame: Hours 12, and 36, 60, Day 7 and Day 30
Patient Global Impression - Change (PGI-C) scale positive response
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.
Time frame: Hours 12, and 36, 60, Day 7 and Day 30
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
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.
Time frame: Baseline to Hour 60 and Day 30
Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score
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.
Time frame: Baseline to Hours 12, 36, 60 Day 7 and Day 30
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