NCT07822321 · Lipocine Inc.
Brexanolone Lifting Outcomes Of Moms
(BLOOM)
What this study is about
The purpose of this research study is to test the study drug, LPCN 1154A, as a possible treatment for postpartum depression (PPD).
View original scientific description
The purpose of this research study is to test the study drug, LPCN 1154A, as a possible treatment for postpartum depression (PPD).
Interventions
DRUG
LPCN 1154A
Oral LPCN 1154A tablets for 48 hours
DRUG
Placebo
Oral Placebo Tablets for 48 hours
Primary outcome measures
Change from baseline in HAM-D17 total score compared to placebo
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Tucson, Arizona
- Canoga Park, California
- Walnut Creek, California
- Aurora, Colorado
- Decatur, Georgia
- Idaho Falls, Idaho
- Chicago, Illinois
- New Orleans, Louisiana
- Las Vegas, Nevada
- Princeton, New Jersey
- Manhattan, New York
- Chapel Hill, North Carolina
And 4 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 16, 2026 · Source of record for eligibility and locations