Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP)

Status: Withdrawn
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: f
View:

• singleton pregnancy

• inpatient or outpatient status

• English speaking

• obstetrician's evaluation and diagnosis of sNVP or HG

• tolerance of oral disintegrating tablet at bedtime

• PUQE score of 10-15; moderate/high or severe

• refractory sNVP

• blood pressure range 70-200 / 45-120

• normal ECG

Locations
United States
Illinois
Northwestern University Asher Center for the Study and Treatment of Depressive Disorders
Chicago
Time Frame
Start Date: 2022-06-13
Completion Date: 2023-10-29
Treatments
Experimental: Mirtazapine Treatment Arm
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.
Sponsors
Leads: Northwestern University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov