EnBrace HR for Depression Treatment and Prevention in Women Trying to Conceive and Early Pregnancy
Depressive Disorder, Pregnancy
About this trial
This is an interventional prevention trial for Depressive Disorder focused on measuring Depressive Disorder, Depression, Antidepressants, Pregnancy, Folate, Dietary Supplements, Omega-3 Fatty Acids, Women's Health, Vitamins
Eligibility Criteria
Inclusion Criteria:
Group 1 (Observational, not-randomized)
Inclusion Criteria:
- Planning pregnancy or pregnant < 28 weeks gestation
- Currently meet criteria for stable remission from MDD, defined as a baseline score of < 10 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
- Current or recent treatment with an AD
- Have elected to discontinue AD medication for pregnancy (may have already begun or completed taper)
- Have a history of a major depressive episode/ Previous Episode of MDD, as verified using the MINI Structured Clinical Interview for DSM-5; have MDD as one of their primary diagnoses
- Has a treating prescribing clinician for the treatment of MDD
Exclusion Criteria:
- Current major depressive episode, as diagnosed on the MINI mood portion
- Significant risk for self-harm or harm to others
- Psychotic symptoms
- Meeting criteria for a primary diagnosis of schizophrenia, an active eating disorder, dementia, delirium, or other cognitive disorder
- Presence of an active substance and/or alcohol abuse disorder within six months prior to screening
- Pernicious anemia or history of gastric bypass surgery
- Seizure disorder and/or on anticonvulsant medications
- Allergy to beeswax, soy, fish, nuts, peanuts, egg, wheat, milk, and/or shellfish
- Non-English speaking
Group 2
Inclusion Criteria:
- Planning pregnancy or pregnant < 28 weeks gestation
- Currently experiencing clinically significant depressive symptoms, defined as a baseline score of > 15 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
- Experiencing a major depressive episode, as verified using the MINI Structured Clinical Interview for DSM-5; have MDD as one of their primary diagnoses
- Has a treating prescribing clinician for the treatment of MDD
Exclusion Criteria:
- Significant risk for self-harm or harm to others
- Psychotic symptoms
- Meeting criteria for a primary diagnosis of schizophrenia, an active eating disorder, dementia, delirium, or other cognitive disorder
- Presence of an active substance and/or alcohol abuse disorder within six months prior to screening
- Pernicious anemia or history of gastric bypass surgery
- Seizure disorder and/or on anticonvulsant medications
- Allergy to beeswax, soy, fish, nuts, peanuts, egg, wheat, milk, and/or shellfish
- Non-English speaking
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Other
Other
EnBrace HR for Prevention of Depressive Relapse (Group 1)
EnBrace HR for Acute Treatment of Major Depression (Group 2)
Prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 weeks. Participants are not currently in a depressive episode per the Mini International Neuropsychiatric Interview (MINI) and are not experiencing clinically significant depression symptoms assessed using the Montgomery Asberg Depression Rating Scale (MADRS) with a score </= 10.
Prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 weeks. Participants are currently in a depressive episode per the Mini International Neuropsychiatric Interview (MINI) and are experiencing clinically significant depression symptoms assessed using the Montgomery Asberg Depression Rating Scale (MADRS) with a score >/= 15.