Pregnancy Clinical Trial
— ESNAPOfficial title:
Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP)
Verified date | April 2024 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | October 29, 2023 |
Est. primary completion date | October 29, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University Asher Center for the Study and Treatment of Depressive Disorders | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Self-Administered Comorbidity Questionnaire (SCQ) | The Comorbidity Questionnaire (CQ) assesses comorbid conditions in clinical and health services research. The questionnaire is self-administered, short, easily understood, and can be completed by individuals without any medical background. It also allows the subject to note the severity of each comorbid conditions and their perception of its impact on their function. | weekly for three weeks | |
Secondary | 9-Item Patient Health Questionnaire (PHQ-9) | The 9-Item Patient Health Questionnaire (PHQ-9) is a self-administered instrument based on the nine DSM-5 criteria listed under criterion A for Major Depressive Disorder. The questionnaire includes criteria based diagnosis of depressive symptoms, assists in identifying treatment goals, determining severity of symptoms, as well as guiding clinical intervention. When considering a diagnosis, the clinician will use clinical interviewing skills to determine whether the symptoms are causing clinically significant distress or impairment and those symptoms are not better explained or attributed to other conditions, such as substance use, medical conditions, or bereavement. | weekly for three weeks | |
Secondary | Generalized Anxiety Disorder Scale, 7-item (GAD-7) | The Generalized Anxiety Scale is a 7-item self-report for symptoms consistent with the Diagnostic and Statistical Manual of Mental Disorders of generalized anxiety disorder. | weekly for three weeks | |
Secondary | Peripartum Events Scale (PES) | The Peripartum Events Scale (PES) captures data from several categories in the birth record. The following categories of events are included: medical and obstetric risk factors, time in operating room, fetal monitoring, surgical complications, infant anthropometrics and outcome, NICU admission, and postpartum complications (such as infection, hemorrhage). Admission to the special care nursery will also be noted. We have modified the original measure to align with current obstetrical practices. The PES will be completed for all enrolled participants. | weekly for three weeks | |
Secondary | PROMIS Global Health | The PROMIS Global Health item scale assesses overall health. The global health items include ratings of the five primary PROMIS domains (physical function, fatigue, pain, emotional distress, social health) as well as perceptions of general health that cut across domains. | weekly for three weeks | |
Secondary | Columbia-Suicide Severity Rating Scale (C-SSRS) | The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide assessment that was developed with NIMH support. The scale is evidence-supported and is part of a national and international public health initiative involving the assessment of suicidality. Suicidal ideation will be assessed at baseline, during, and 28 days after treatment cessation if there were any abnormalities during the trial. | weekly for three weeks | |
Secondary | plasma mirtazapine concentrations | Genotypes that determine the activities of CYP2D6, and minor pathways 3A4/5 and 1A2, will be explored for associations with mirtazapine plasma concentrations. | weekly for three weeks |
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