COMPLETED

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

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Conditions

Depression, PostpartumPostpartum DepressionPost-partum DepressionPostnatal DepressionPost-Natal DepressionDepressionNORA520NuMom

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Placebo-Controlled, Double-Blinded, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Oral NORA520 in Female Adults With Severe Postpartum Depression

Quick Facts

Study Start:2024-03-28
Study Completion:2025-10-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06285916

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Are willing and able to provide signed informed consent to participate in the study and to comply with all study procedures and scheduled visits
  2. * Are an adult female between 18 and 45 years of age, inclusive;
  3. * 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;
  4. * Have a negative pregnancy test at Screening and Day 1 (prior to dosing);
  5. * Have had a depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery
  6. * Are ≤9 months postpartum at Screening.
  1. * Have a history or current diagnosis or current treatment of bipolar disorder, schizophrenia, or schizoaffective disorder;
  2. * Have had recorded treatment failure of ≥2 different antidepressant classes (e.g., SSRI, SNRI) in the current or previous episode;
  3. * Are currently experiencing active psychosis per Investigator assessment, or are taking typical or atypical antipsychotic medication;
  4. * Have a history of suicidal behavior within 2 years;
  5. * Have a history or current diagnosis of sleep apnea or narcolepsy.

Contacts and Locations

Study Locations (Sites)

Pillar Clinical Research
Bentonville, Arkansas, 72712
United States
Advanced Research Center
Anaheim, California, 92805
United States
Alliance Research Institute
Canoga Park, California, 91304
United States
Cenexel Clinical Research
Sherman Oaks, California, 91403
United States
Cenexel Clinical Research
Torrance, California, 90504
United States
MedOne Clinical Research
Miami, Florida, 33145
United States
Meridian International Research, Inc.
Miami Gardens, Florida, 33014
United States
Combined Research
Orlando, Florida, 32807
United States
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
United States
GCP Research
St. Petersburg, Florida, 33607
United States
Cenexel Clinical Research
Atlanta, Georgia, 30331
United States
CenExel Clinical Research
Decatur, Georgia, 30030
United States
CenExel Clinical Research
Savannah, Georgia, 31405
United States
Insight Hospital and Medical Center Chicago
Chicago, Illinois, 60616
United States
Zucker Hillside Hospital
Glen Oaks, New York, 11004
United States
Monroe Biomedical Research
Monroe, North Carolina, 28112
United States
Maximos Ob/Gyn
League City, Texas, 77573
United States
Pillar Clinical Researc
Richardson, Texas, 75080
United States

Collaborators and Investigators

Sponsor: DuKang Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-28
Study Completion Date2025-10-06

Study Record Updates

Study Start Date2024-03-28
Study Completion Date2025-10-06

Terms related to this study

Keywords Provided by Researchers

  • Depression
  • Postpartum Depression
  • NORA520
  • Postnatal Depression
  • NuMom

Additional Relevant MeSH Terms

  • Depression, Postpartum
  • Postpartum Depression
  • Post-partum Depression
  • Postnatal Depression
  • Post-Natal Depression