Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
TWi Biotechnology, Inc.
Age
18–45
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression
