LPCN 1154A for Postpartum Depression

Recruiting at 21 trial locations

Overseen By Vice President of Clinical Development

Age: < 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Lipocine Inc.

Disqualifiers: Bipolar, Schizophrenia, Psychosis, Seizure, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 4 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, LPCN 1154A, to determine if it can alleviate symptoms in women with severe postpartum depression (PPD). Researchers aim to assess the drug's effectiveness in reducing depression and anxiety symptoms and identify any potential side effects. Women who experienced a depressive episode starting late in pregnancy or shortly after giving birth, and are less than a year postpartum, may be suitable candidates for this study. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment for PPD.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that LPCN 1154A is likely to be safe for humans?

Research has shown that LPCN 1154A is under study as a treatment for postpartum depression. Information is still being collected on how well participants tolerate LPCN 1154A. An independent group reviews the safety data throughout the study to ensure participant safety.

As a Phase 3 trial, earlier studies have already examined the safety and potential side effects of LPCN 1154A. These studies are crucial as they help determine if the treatment is generally safe for use.

In summary, while specific safety data for LPCN 1154A is still being gathered, earlier phases usually indicate that the treatment is fairly well-tolerated if it has reached this stage. However, discussing any concerns with a healthcare professional remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for postpartum depression?

Unlike the standard treatments for postpartum depression, which often include antidepressants like SSRIs that can take weeks to show effectiveness, LPCN 1154A is designed to work much faster. Researchers are particularly excited about LPCN 1154A because it is formulated as an oral tablet, which could offer a more convenient and less invasive alternative to the intravenous treatments currently available. The potential for LPCN 1154A to provide rapid relief from postpartum depression symptoms makes it a promising new option for new mothers in need of timely support.

What evidence suggests that LPCN 1154A might be an effective treatment for postpartum depression?

Previous studies have shown that LPCN 1154A holds promise as a treatment for postpartum depression (PPD). This trial will evaluate LPCN 1154A, which aims to reduce depression symptoms and may also alleviate anxiety in patients with severe PPD. Research suggests that LPCN 1154A affects certain brain areas involved in mood control. Although specific data on its effectiveness for PPD is limited, the treatment uses an active ingredient known to help with similar conditions. This makes LPCN 1154A a hopeful option for those experiencing severe postpartum depression. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for women experiencing severe postpartum depression (PPD) after giving birth. The study seeks participants who are currently in the postpartum period.

Inclusion Criteria

I gave birth less than 12 months ago.

Hamilton Depression Rating Scale (HAM-D) 17-item score indicative of severe depression

I am a woman aged between 15 and 45.

Exclusion Criteria

History of bipolar disorder, schizophrenia, or schizoaffective disorder

I have had a seizure in the last 6 months.

Currently experiencing active psychosis per Investigator assessment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LPCN 1154A or placebo to assess its efficacy in reducing depressive and anxiety symptoms in women with severe postpartum depression

4 weeks

Visits at Baseline, Hours 12, 36, 60, Day 7, and Day 30

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LPCN 1154A

Trial Overview The study is testing LPCN 1154A, a potential new treatment for PPD. Participants will either receive this drug or a placebo to compare its effectiveness and safety in reducing depressive and anxiety symptoms.

How Is the Trial Designed?

Group I: LPCN 1154A Tablets Experimental Treatment 1 Intervention

LPCN 1154A

Group II: Placebo Tablets Placebo Group 1 Intervention

Placebo Tablets

Who Is Running the Clinical Trial?

Lipocine Inc.

Lead Sponsor

Trials

7

Recruited

760+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06979544

A Study to Assess the Safety and Efficacy of Oral LPCN ... 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:.

2. ir.lipocine.com ir.lipocine.com/2025-09-30-Lipocine-Provides-Progress-Update-on-LPCN-1154-Phase-3-Clinical-Trial-in-Postpartum-Depression-PPD

Lipocine Provides Progress Update on LPCN 1154 Phase 3 ... The study is progressing on track with one-third of planned patients randomized. Topline results are anticipated in the second quarter of 2026.

3. prnewswire.com prnewswire.com/news-releases/lipocine-provides-progress-update-on-lpcn-1154-phase-3-clinical-trial-in-postpartum-depression-ppd-302570209.html

Lipocine Provides Progress Update on LPCN 1154 Phase ... LPCN 1154 is expected to have characteristics that could be particularly appealing to patients with PPD, acutely elevated suicide risk, and in ...

4. psychiatrictimes.com psychiatrictimes.com/view/progress-update-lpcn-1154-for-the-treatment-of-postpartum-depression

LPCN 1154 for the Treatment of Postpartum Depression The trial aims to determine if LPCN 1154 reduces depressive and anxiety symptoms in subjects with severe PPD, and how well participants tolerate ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/lipocine-phase-iii-trial/

Lipocine begins dosing in Phase III postpartum depression ... Lipocine has initiated subject dosing in its two-arm, blinded, randomised Phase III trial of LPCN 1154 (oral brexanolone) for postpartum depression (PPD).