LPCN 1154A for Postpartum Depression

Recruiting at 9 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

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+