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

• Status: Enrolling by invitation
• Trial end date: 2024-06-13
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Mirtazapine

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