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

NCT05452174 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: STU00215676R21HD105101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Severe Nausea and Vomiting; Hyperemesis Gravidarum

Keywords

pregnancy; severe nausea; vomiting

Outcome Measures

Primary Outcomes (1)

• change in Pregnancy Unique Quality of Emesis (PUQE) score

  We will utilize the PUQE scale to capture the severity of nausea and vomiting in pregnancy based on three physical symptoms: nausea, vomiting, and retching over the previous 24 hours. A PUQE score of \< 6 is considered mild, a score from 7-12 is moderate, and a score of 13+ is considered severe. This scale will be entered daily in REDCap directly by the participant.

  daily for three weeks

Secondary Outcomes (7)

• Self-Administered Comorbidity Questionnaire (SCQ)

  weekly for three weeks

• 9-Item Patient Health Questionnaire (PHQ-9)

  weekly for three weeks

• Generalized Anxiety Disorder Scale, 7-item (GAD-7)

  weekly for three weeks

• Peripartum Events Scale (PES)

  weekly for three weeks

• PROMIS Global Health

  weekly for three weeks

Study Arms (1)

Mirtazapine Treatment Arm

EXPERIMENTAL

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.

Drug: Mirtazapine

Interventions

Mirtazapine DRUG

Mirtazapine, sold under the brand name Remeron, is an atypical antidepressant, and as such is used primarily to treat depression.

Also known as: Remeron

Mirtazapine Treatment Arm

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Northwestern University Asher Center for the Study and Treatment of Depressive Disorders

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Abramowitz A, Miller ES, Wisner KL. Treatment options for hyperemesis gravidarum. Arch Womens Ment Health. 2017 Jun;20(3):363-372. doi: 10.1007/s00737-016-0707-4. Epub 2017 Jan 9.

  PMID: 28070660 BACKGROUND

• Fejzo MS, MacGibbon KW, Wisner KL. Pregnant, miserable, and starving in 21st century America. AJOG Glob Rep. 2022 Dec 5;3(1):100141. doi: 10.1016/j.xagr.2022.100141. eCollection 2023 Feb.

  PMID: 36536797 BACKGROUND

MeSH Terms

Conditions

Nausea; Vomiting; Hyperemesis Gravidarum

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Katherine L Wisner, M.D., M.S.

  Northwestern University (adjunct) now at Children's National Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 11, 2022
• Study Start: June 13, 2022
• Primary Completion: October 29, 2023
• Study Completion: October 29, 2023
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)