A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression
Purpose
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.
Conditions
- Depression, Postpartum
- Postpartum Depression
- Post-partum Depression
- Postnatal Depression
- Post-Natal Depression
Eligibility
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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.
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NORA520 Tablets Dose 1 |
NORA520 Tablets Dose 1 |
|
|
Experimental NORA520 Tablets Dose 2 |
NORA520 Tablets Dose 2 |
|
|
Placebo Comparator Placebo Tablets |
Placebo Tablets |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Gerbera Therapeutics, Inc.
