A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Po… (NCT06285916) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression
United States93 participantsStarted 2024-03-28
Plain-language summary
The purpose of this research study is to test the study drug, NORA520, as a possible treatment for severe postpartum depression (PPD). The trial aims to determine:
* How well NORA520 is tolerated and what side effects it may cause
* If NORA520 reduces depressive symptoms in subjects with severe PPD
* The amount of NORA520 in the blood at various times after taking the study drug; this provides information that helps determine how often NORA520 should be taken
* In a subset of subjects, the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups. All subjects will take the study drug for 3 days.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence, severity, and causality of AEs, SAEs, and AESIs
Timeframe: Up to Day 30
2
Change from baseline in HAM-D17 total score compared to placebo