EnBrace HR for PMS With Prominent Mood Symptoms or Menstrual Related Mood Disorders

NCT04123483 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2019P002454
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premenstrual Syndrome; Premenstrual Dysphoric Disorder; Premenstrual Tension; Menstrual Related Mood Disorder

Keywords

PMS; Folate; Omega-3 Fatty Acids; Vitamins; Women's Health; Dietary Supplements; PMDD; MRMD; Menstrual Related Mood Disorder; Premenstrual Tension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

EnBrace HR for Acute Treatment of PMS and MRMD

EXPERIMENTAL

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).

Drug: EnBrace HR Softgel

Interventions

EnBrace HR Softgel DRUG

Prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 8 week study

Also known as: EnBrace HR

EnBrace HR for Acute Treatment of PMS and MRMD

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Regular menstrual cycles, 23-35 days in length.
• MRMD diagnosis based on the DRSP items, with: at least 1 or more core symptoms occurring during the luteal phase of the menstrual cycle for at least the past three months by patient history, including: 1) low mood, 2) hopelessness, 3) feeling worthless or guilty, 4) feeling anxious or "keyed up" or "on edge," 5) mood swings, 6) more sensitive to rejection or to hurt feelings, 7) feeling angry/irritable, or 8) having interpersonal conflicts.
• Patients must also have at least 1 associated symptom on the DRSP that is not considered a core symptom that occurs during the luteal/premenstrual phase of the menstrual cycle.
• Currently experiencing clinically significant MRMD symptoms, defined as ≥ 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).
• Negative serum Human Chorionic Gonadotropin (HCG) at baseline, and negative urine HCG at visits 3 and 5.
• Willingness to use adequate contraceptive methods during the study, if sexually active. Hormonal contraceptives are allowed if the premenstrual symptoms still meet study criteria despite use and patient has been on a stable regimen for \>3 months.
• Good general health.

You may not qualify if:

• Amenorrhea or irregular menstrual periods (defined as unable to predict within 7 days) during past 2 months.
• Pregnant and lactating women.
• Women taking a prenatal vitamin, methotrexate, fluorouracil, colchicine, bromocriptine, Gonadotropin-Releasing Hormone (GnRH) agonists, vitamin B6 (\>100 mg), calcium supplements (\>1500 mg per day), or para-aminosalicylic acid.
• Significant risk for self-harm or harm to others.
• Meet criteria for a primary diagnosis of schizophrenia, bipolar disorder, an active eating disorder of anorexia or bulimia, dementia, delirium, or other cognitive disorder.
• Current major depressive episode or anxiety disorder that is a primary focus of current treatment. Patients may be on an antidepressant used for maintenance treatment if the dose is not changed intermittently to address premenstrual symptoms; dose must be stable for at least 8 weeks prior to study entry.
• Presence of an active substance and/or alcohol abuse disorder within six months prior to screening.
• Known low B12 levels, pPernicious anemia or history of gastric bypass surgery or bariatric surgery.
• Seizure disorder or current use of an anticonvulsant medication
• Allergy to beeswax, soy, fish, nuts, peanuts, egg, wheat, milk, and/or shellfish.
• Non-English speaking.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Premenstrual Syndrome; Premenstrual Dysphoric Disorder

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Marlene P Freeman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Center for Women's Mental Health

Model Details: A pilot study of EnBrace HR in a single group of women who experience PMS with prominent mood symptoms or a menstrual related mood disorder (MRMD). All women will be experiencing clinically significant menstrual related mood symptoms at the time of enrollment. In this study, EnBrace HR is studied for acute treatment PMS with prominent mood symptoms and MRMD.

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2022
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)