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NORA520 for Postpartum Depression (NuMom Trial)

Phase 2
Recruiting
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
Must not have
History or current diagnosis of sleep apnea or narcolepsy
Currently experiencing active psychosis per Investigator assessment or taking typical or atypical antipsychotic medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to days 4, 8, and 30
Awards & highlights

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged between 18 and 45.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with sleep apnea or narcolepsy.
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I am not currently experiencing psychosis nor taking antipsychotic medication.
Select...
I have tried at least two different types of antidepressants without success.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in HAM-D17 total score compared to placebo
Incidence, severity, and causality of AEs, SAEs, and AESIs
Secondary study objectives
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
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: NORA520 Tablets Dose 2Experimental Treatment1 Intervention
NORA520 Tablets Dose 2
Group II: NORA520 Tablets Dose 1Experimental Treatment1 Intervention
NORA520 Tablets Dose 1
Group III: Placebo TabletsPlacebo Group1 Intervention
Placebo Tablets

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Who is running the clinical trial?

Gerbera Therapeutics, Inc.Lead Sponsor
~60 spots leftby Feb 2026
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