Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP) (ESNAP)
Pregnancy, Severe Nausea and Vomiting, Hyperemesis Gravidarum
About this trial
This is an interventional treatment trial for Pregnancy focused on measuring pregnancy, severe nausea, vomiting
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- allergic or adverse reaction to mirtazapine
- patient has bipolar disorder
- subjects with active depression, or history of or current active suicidal ideation or attempt
- subjects with renal or hepatic impairment
- substance about in last 6 months
- use of medicinal or recreational cannabis-derived products in the last 6 months
- taking MAOIs, strong CYP3A inducers or inhibitors, and SSRIs
Sites / Locations
- Children's National Hospital
- Northwestern University Asher Center for the Study and Treatment of Depressive Disorders
Arms of the Study
Arm 1
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.