Cancellation of funding contract
EnBrace HR for Premenstrual Syndrome (PMS) With Prominent Mood Symptoms (or Menstrual Related Mood Disorders, MRMD)
Sponsor study identifier
interventional
0
1 country
1
Study Start
November 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to assess a novel nutritional supplement developed for prenatal health and mood benefits, and to determine whether there is preliminary evidence for efficacy in Menstrual Related Mood Disorders (MRMD), including PMS with Prominent Mood Symptoms and PMDD.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 9, 2019
Actual (reported)October 11, 2019
Actual (reported)November 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Rate of Treatment Response to EnBrace Therapy Measured Using The Daily Record of Severity of Problems (DRSP)
Experience a response (50% improvement in MRMD symptoms) to EnBrace therapy, as assessed by the DRSP (≥ 50% decrease in DRSP score during the luteal phase). The DSRP involves daily rating of scale items and ranking based on severity for each day of the menstrual cycle. The DRSP includes 21 symptom items grouped within 11 domains. An individual records the score for each item on each day using the following scale of 1 to 6: 1=not at all, 2=minimal, 3=mild, 4=moderate, 5=severe, 6=extreme. Clinically significant MRMD symptoms are defined as a ≥ 30% increase in the total DRSP score from the mid-follicular phase (average of DRSP scores for days 6-10) to the late-luteal phase (average of DRSP scores for last 5 days prior to menstrual bleeding).
Assessed daily for 8 weeks of treatment
Prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 8 weeks. Participants are currently experiencing clinically significant MRMD symptoms, defined as a ≥ 30% increase in the total Daily Record of Severity of Problems Scale (DRSP) score from the mid-follicular phase (average of DRSP scores for days 6-10) to the late-luteal phase (average of DRSP scores for last 5 days prior to menstrual bleeding).
Prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 8 week study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Marlene P Freeman, MD
Massachusetts General Hospital
0 participants (actual enrollment reported by the registry).
First Submitted
October 9, 2019
First Posted
October 11, 2019
Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder
Contact the study team to confirm eligibility.
Study Start
November 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 2, 2020
Record last verified: 2019-12
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Source: ClinicalTrials.gov.
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