LPCN 1154A for Postpartum Depression Treatment

Brexanolone Lifting Outcomes Of Moms

Recruiting Phase 3 Interventional Study
Depression, Postpartum Postpartum Depression (PPD) Post-partum Depression Postnatal Depression Post-Natal Depression Peripartum Depression
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
15 – 45
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Lipocine Inc. · Industry
Who this trial is looking for

This trial is looking for women aged 15 to 45 who are experiencing severe postpartum depression. Participants will take the study drug LPCN 1154A to see if it helps reduce their depressive symptoms and to learn about any side effects.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am a female between 15 and 45 years old.
  • I have had a depressive episode that started during my pregnancy or within 4 weeks after giving birth.
  • I am less than 18 months postpartum at the time of screening.
  • I have a severe level of depression as measured by a specific scale.

You may not be able to join if

  • I have a history of bipolar disorder.
  • I have a history of schizophrenia or schizoaffective disorder.
  • I am currently experiencing active psychosis.
  • I have had suicidal behavior related to my current depressive episode.
  • I have had a seizure within the last 6 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About 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

Trial Locations
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Eligibility Criteria
Key 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…
Contacts

Vice President of Clinical Development

801-519-4363

siteinquiry@lipocine.com

CONTACT