Mirtazapine for Hyperemesis Gravidarum

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Northwestern University Asher Center for the Study and Treatment of Depressive Disorders, Chicago, IL
Hyperemesis Gravidarum+4 More
Mirtazapine - Drug
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

The primary objective of this proposal is to conduct an early Phase 2 clinical trial to determine the acceptability, dosing, tolerability and safety of mirtazapine for severe nausea and vomiting of pregnancy (sNVP) that is not adequately responsive to current standard treatments. This plan mirrors clinical practice since commonly prescribed antiemetic/ antinauseant drugs will be tested for efficacy before treating with mirtazapine.

Eligible Conditions

  • Hyperemesis Gravidarum
  • Nausea
  • Pregnant State

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hyperemesis Gravidarum

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: weekly for three weeks

daily for three weeks
change in Pregnancy Unique Quality of Emesis (PUQE) score
weekly for three weeks
9-Item Patient Health Questionnaire (PHQ-9)
Columbia-Suicide Severity Rating Scale (C-SSRS)
Generalized Anxiety Disorder Scale, 7-item (GAD-7)
PROMIS Global Health
Peripartum Events Scale (PES)
Self-Administered Comorbidity Questionnaire (SCQ)

Trial Safety

Safety Progress

1 of 3

Other trials for Hyperemesis Gravidarum

Side Effects for

Sertraline and Mirtazapine
50%increased appetite
50%lightheadedness
42%decreased libido (women)
33%diarrhea
33%somnolence
28%heartburn
28%tremor
28%urinary dysfunction
22%sweating
22%headache
22%skin problems
22%blurry vision
22%forgetfulness
17%constipation
17%decreased appetite
17%dry mouth
17%incoordination
11%impaired concentration
11%apathy
11%emesis
11%nausea
11%restlessness
11%insomnia
8%sexual dysfunction (women)
6%nervousness
6%fatigue
0%sexual dysfunction (men)
0%bruising
0%decreased libido (men)
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01178671) in the Sertraline and Mirtazapine ARM group. Side effects include: increased appetite with 50%, lightheadedness with 50%, decreased libido (women) with 42%, diarrhea with 33%, somnolence with 33%.

Trial Design

1 Treatment Group

Mirtazapine Treatment Arm
1 of 1
Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Mirtazapine · No Placebo Group · Phase 1 & 2

Mirtazapine Treatment Arm
Drug
Experimental Group · 1 Intervention: Mirtazapine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirtazapine
2012
Completed Phase 4
~4150

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weekly for three weeks
Closest Location: Northwestern University Asher Center for the Study and Treatment of Depressive Disorders · Chicago, IL
Photo of Chicago 1Photo of Chicago 2Photo of Chicago 3
2021First Recorded Clinical Trial
1 TrialsResearching Hyperemesis Gravidarum
1 CompletedClinical Trials

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,421 Previous Clinical Trials
717,352 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,785 Previous Clinical Trials
2,221,773 Total Patients Enrolled
1 Trials studying Hyperemesis Gravidarum
31 Patients Enrolled for Hyperemesis Gravidarum
Katherine L Wisner, M.D., M.S.Principal InvestigatorNorthwestern University
2 Previous Clinical Trials
210 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · Female Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had a positive obstetrician's evaluation and diagnosis of sNVP or HG.
You have a score of 10-15 on the PUQE.
You have a normal electrocardiogram.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.