Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP)
NCT ID: NCT05452174
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2022-06-13
2023-10-29
Brief Summary
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Detailed Description
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Mirtazapine is a promising drug to repurpose for sNVP. It has potent anti-emetic properties and is available as an oral disintegrating formulation. It is used off-label to treat NV during cancer chemotherapy, prevent post-surgical nausea and vomiting and for gastroparesis. It is marketed as the serotonin-norepinephrine reuptake inhibitor antidepressant Remeron®. Mirtazapine has multiple receptor effects beyond those involved in reducing depressive symptoms. In cancer and chemotherapy patients, it produces rapid resolution of nausea and vomiting by blocking physiologic inputs that coordinate emesis. It is hypothesized that repurposing mirtazapine for obstetric use overcomes the challenges of traditional pathways to develop new agents because its pharmacokinetics, safety and dosing have been established for general populations of patients and exposure data are available because it is prescribed to pregnant persons with depression.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Mirtazapine
Mirtazapine, sold under the brand name Remeron, is an atypical antidepressant, and as such is used primarily to treat depression.
Interventions
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Mirtazapine
Mirtazapine, sold under the brand name Remeron, is an atypical antidepressant, and as such is used primarily to treat depression.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
49 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Northwestern University
OTHER
Responsible Party
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Principal Investigators
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Katherine L Wisner, M.D., M.S.
Role: PRINCIPAL_INVESTIGATOR
Northwestern University (adjunct) now at Children's National Hospital
Locations
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Northwestern University Asher Center for the Study and Treatment of Depressive Disorders
Chicago, Illinois, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STU00215676
Identifier Type: -
Identifier Source: org_study_id