A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression

Launched by DUKANG PHARMACEUTICALS, INC. · Feb 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called NORA520 to see if it can help women with severe postpartum depression (PPD). Postpartum depression is a type of depression that can occur after giving birth, and this study aims to find out how well the medication works, how safe it is, and any side effects it might cause. Participants will take NORA520 for three days, and the researchers will also check how much of the drug is in their blood and breastmilk, if applicable.

To join the study, women must be between 18 and 45 years old and have experienced depression starting from late pregnancy to within four weeks after delivery. Participants should not currently be breastfeeding or must agree to stop breastfeeding for two weeks during the trial. The study is currently looking for volunteers, and it's important for potential participants to discuss their health history with the study team, especially regarding any previous mental health issues. Overall, this trial hopes to find a new treatment option to help women struggling with severe postpartum depression.

Gender

FEMALE

Eligibility criteria

• Key Inclusion Criteria:
• • Are willing and able to provide signed informed consent to participate in the study and to comply with all study procedures and scheduled visits
• • Are an adult female between 18 and 45 years of age, inclusive;
• • Have either ceased lactating at Screening, or if still lactating or actively breastfeeding at Screening, agree to temporarily cease giving breastmilk to their infant(s) from just prior to first dose of study drug on Day 1 through Day 14;
• • Have a negative pregnancy test at Screening and Day 1 (prior to dosing);
• • Have had a depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery
• • Are ≤9 months postpartum at Screening.
• Key Exclusion Criteria:
• • Have a history or current diagnosis or current treatment of bipolar disorder, schizophrenia, or schizoaffective disorder;
• • Have had recorded treatment failure of ≥2 different antidepressant classes (e.g., SSRI, SNRI) in the current or previous episode;
• • Are currently experiencing active psychosis per Investigator assessment, or are taking typical or atypical antipsychotic medication;
• • Have a history of suicidal behavior within 2 years;
• • Have a history or current diagnosis of sleep apnea or narcolepsy.