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

• Status: Withdrawn
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: JayMac Pharmaceuticals, LLC

Criteria

Inclusion Criteria:

1. Regular menstrual cycles, 23-35 days in length.

2. 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.

3. 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.

4. 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).

5. Negative serum Human Chorionic Gonadotropin (HCG) at baseline, and negative urine HCG at visits 3 and 5.

6. 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.

7. Good general health.

Exclusion Criteria:

1. Amenorrhea or irregular menstrual periods (defined as unable to predict within 7 days) during past 2 months.

2. Pregnant and lactating women.

3. 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.

4. Significant risk for self-harm or harm to others.

5. Meet criteria for a primary diagnosis of schizophrenia, bipolar disorder, an active eating disorder of anorexia or bulimia, dementia, delirium, or other cognitive disorder.

6. 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.

7. Presence of an active substance and/or alcohol abuse disorder within six months prior to screening.

8. Known low B12 levels, pPernicious anemia or history of gastric bypass surgery or bariatric surgery.

9. Seizure disorder or current use of an anticonvulsant medication

10. Allergy to beeswax, soy, fish, nuts, peanuts, egg, wheat, milk, and/or shellfish.

11. Non-English speaking.