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NORA520 Dose 1 for Postpartum Depression (NuMom Trial)

Phase 2

Waitlist Available

Research Sponsored by Gerbera Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult female between 18 and 45 years of age

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to days 4, 8, and 30

Awards & highlights

NuMom Trial Summary

This trial is testing a drug called NORA520 to see if it can help treat severe postpartum depression. The study will look at how well the drug is tolerated, any side effects it may

Who is the study for?

This trial is for adults with severe postpartum depression. Participants will be randomly assigned to one of three groups and will take the study drug or placebo for 3 days.Check my eligibility

What is being tested?

The study tests NORA520's effectiveness in reducing depressive symptoms, its safety, tolerability, how it's processed by the body, and if it transfers into breastmilk. There are two different doses of NORA520 being compared against a placebo.See study design

What are the potential side effects?

Potential side effects of NORA520 may include reactions related to medication tolerance issues but specific side effects are not listed here as they are part of what the trial aims to determine.

NuMom Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman aged between 18 and 45.

NuMom Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to days 4, 8, and 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to days 4, 8, and 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to days 4, 8, and 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in HAM-D17 total score compared to placebo

Incidence, severity, and causality of AEs, SAEs, and AESIs

Secondary outcome measures

Change from baseline in Clinical Global Impression - Severity (CGI-S) score

Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score

Change from baseline in HAM-D17 subscale and individual item scores

+7 more

NuMom Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: NORA520 Dose 2Experimental Treatment1 Intervention

NORA520 Dose 2

Group II: NORA520 Dose 1Experimental Treatment1 Intervention

NORA520 Dose 1

Group III: PlaceboPlacebo Group1 Intervention

Placebo

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gerbera Therapeutics, Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any age restrictions for potential participants in this medical study, specifically regarding individuals above the age of 50?

"Individuals aged 18 to 45 years old are eligible for inclusion in this clinical trial."

Answered by AI

Which individuals meet the criteria for participation in this research study?

"To qualify for participation in this research, individuals must be experiencing postpartum depression and fall between the ages of 18 and 45. The study aims to enroll approximately 90 participants."

Answered by AI

How many sites are involved in the execution of this study?

"The ongoing trial is operational at 6 distinct sites, with facilities situated in Canoga Park, Saint Petersburg, and Miami Gardens among others. Opting for the nearest site can lessen travel inconveniences during your potential involvement."

Answered by AI

What is the level of safety associated with NORA520 Dose 2 in individuals?

"Our team at Power rates the safety of NORA520 Dose 2 as a 2 on our scale, reflecting that although there is data supporting its safety in this Phase 2 trial, no evidence yet supports its effectiveness."

Answered by AI

Is this clinical trial currently open for enrollment?

"According to information available on clinicaltrials.gov, this particular research endeavor is no longer in the recruitment phase. The trial was initially registered on February 1st, 2024, and its latest update was noted on February 22nd of the same year. Despite this trial reaching full capacity, it's noteworthy that there are approximately 1406 alternative studies actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06285916.