The NORA520 Severe Postpartum Depression Clinical Research Study
The NORA520 Severe Postpartum Depression Clinical Research Study
About The NORA520 Study
The NORA520 research study is evaluating whether NORA520, an investigational drug, is safe and effective in improving symptoms of severe postpartum depression in women. NORA520 will be compared to placebo, a pill with no expected benefits.
NORA520 is an immediate-release, fast-acting tablet taken by mouth. It is taken for only 3 consecutive days, for a total of 5 doses; once in the evening on day one, and then once in the morning and once in the evening on days two and three.
The study will last up to 60 days, including screening, study treatment, and follow-up periods.
Participants who successfully enroll into the study will be randomly assigned to receive either NORA520, or placebo. The placebo pill looks like the NORA520 tablet, although it does not contain any active ingredient and is not expected to provide any benefit. All investigational medication will be provided to participants by healthcare professionals, and will be monitored through inpatient stays for the entirety of the course of treatment.
Study Criteria
Are a female adult age 18-45 (inclusive)
Have been diagnosed with postpartum depression
And have had a depressive episode beginning between the 3rd trimester and 4th week postpartum
Have had a baby within the last 9 months
Participation Overview
This study’s main purpose is to evaluate both the safety and efficacy of NORA520 in patients with severe postpartum depression. This is a randomized, double-blind study, which means participants and study staff will not know whether participants receive NORA520 or placebo. The placebo has no active medication in it and will have no effect on the person taking it. This will allow the study to verify if NORA520 provides a potential benefit on the symptoms of severe postpartum depression versus placebo.
All participants who are eligible and successfully enroll in this study will participate for up to 60 days, composed of 1 screening visit, a 3 night in-patient stay, and 2 follow-up visits. The screening visit occurs within 30 days before the study treatment starts, followed by the study treatment period of 3 days during which you will remain in the study site while you are receiving the study drug and will be discharged on Day 4. Afterwards, there will be a follow-up period of approximately 30 days, during which you will return to the study site on two separate occasions for study visits (Day 8 and Day 30). In addition, those enrolled will need to refrain from breastfeeding their child for at least 14 days while in the trial. Breast pumps will be supplied.
Qualified participants will receive all study-related care and study medication at no cost, and compensation for time, travel, and childcare may be available. Participants will be asked to visit the study site for the 4 days of study treatment, as well as the 2 follow up visits. These scheduled visits may include physical exams, vital signs, blood sampling, questionnaires, electrocardiograms, and/or urine testing.
