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Antidepressant

Mirtazapine for Morning Sickness (ESNAP Trial)

Phase 1 & 2
Waitlist Available
Led By Katherine L Wisner, M.D., M.S.
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obstetrician's evaluation and diagnosis of sNVP or HG
Refractory sNVP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly for three weeks
Awards & highlights

ESNAP Trial Summary

This trial is to test the safety and if mirtazapine can help with severe nausea and vomiting during pregnancy that isn't helped by other standard treatments.

Who is the study for?
This trial is for English-speaking pregnant women experiencing severe nausea and vomiting that hasn't improved with standard treatments. They must have a specific score indicating moderate to severe symptoms, normal blood pressure, a healthy heart rhythm, be able to take an oral tablet at bedtime, and have a single pregnancy.Check my eligibility
What is being tested?
The E-SNAP trial is testing the drug Mirtazapine's effectiveness in treating severe morning sickness when usual medications don't work. Participants will first try common anti-nausea drugs before moving on to Mirtazapine.See study design
What are the potential side effects?
Mirtazapine may cause drowsiness, increased appetite leading to weight gain, dry mouth, constipation or diarrhea. It can also potentially lead to mood changes or agitation.

ESNAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My obstetrician diagnosed me with severe morning sickness or HG.
Select...
My condition is resistant to standard treatments.

ESNAP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly for three weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly for three weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vomiting
Secondary outcome measures
9-Item Patient Health Questionnaire (PHQ-9)
Columbia-Suicide Severity Rating Scale (C-SSRS)
Anxiety Disorders
+4 more

Side effects data

From 2014 Phase 4 trial • 38 Patients • NCT01178671
44%
nausea
43%
decreased libido (men)
43%
sexual dysfunction (men)
33%
fatigue
28%
sweating
28%
somnolence
28%
dry mouth
28%
decreased appetite
28%
urinary dysfunction
28%
constipation
28%
diarrhea
28%
tremor
27%
decreased libido (women)
22%
forgetfulness
22%
lightheadedness
22%
impaired concentration
18%
sexual dysfunction (women)
17%
heartburn
17%
apathy
17%
emesis
17%
headache
11%
blurry vision
11%
increased appetite
11%
incoordination
11%
insomnia
6%
nervousness
6%
skin problems
6%
bruising
6%
restlessness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sertraline and Sugar Pill
Sertraline and Mirtazapine

ESNAP Trial Design

1Treatment groups
Experimental Treatment
Group I: Mirtazapine Treatment ArmExperimental Treatment1 Intervention
Subjects will be administered the initial dose of mirtazapine, with dosage progressively increased over the course of the study. The initial dose of mirtazapine is 15 mg tablet, once per day. The dose will be increased weekly as tolerated up to 45 mg per day. The dose will be increased by 15 mg each week if the lower dose is tolerated without significant side effects. That is to say, the subject will take 15 mg/day every day for the first week, 30 mg/day every day for the second week, and 45 mg/day every day for the third week, with the option of the subject continuing the medication for the remainder of the pregnancy. If subjects choose to discontinue the mirtazapine, there will be a tapering regimen: if a patient is taking 45 mg at the end of week 3, they will begin a taper (by week) of 30 to 15 to 7.5 to 0 mg. If they relapse or has discontinuation symptoms, the previous effective dose will be given. They may attempt to taper again with the same approach.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirtazapine
FDA approved

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,575 Previous Clinical Trials
910,578 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,951 Previous Clinical Trials
2,660,746 Total Patients Enrolled
1 Trials studying Morning Sickness
2,359 Patients Enrolled for Morning Sickness
Katherine L Wisner, M.D., M.S.Principal InvestigatorNorthwestern University
2 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

Mirtazapine (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT05452174 — Phase 1 & 2
Morning Sickness Research Study Groups: Mirtazapine Treatment Arm
Morning Sickness Clinical Trial 2023: Mirtazapine Highlights & Side Effects. Trial Name: NCT05452174 — Phase 1 & 2
Mirtazapine (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05452174 — Phase 1 & 2

Frequently Asked Questions

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

Does the trial have an age cutoff, and if so, what is it?

"This medical trial is only available to those aged 18 to 49. On the other hand, there are 42 studies designed for minors and 116 specifically geared towards participants over 65 years old."

Answered by AI

Are there any opportunities for enrollment in this experiment?

"According to clinicaltrials.gov, this particular medical experiment is not currently seeking participants; the posting was initially made on June 13th and last updated on September 26 of 2022. Nevertheless, there are still 190 other trials presently recruiting patients for participation."

Answered by AI

May I partake in this clinical trial?

"The requirements to join this medical test are hyperemesis gravidarum and an age range between 18-49. 25 participants in total will be accepted for the trial."

Answered by AI

Who else is applying?

What site did they apply to?
Northwestern University Asher Center for the Study and Treatment of Depressive Disorders
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

~2 spots leftby Jun 2024