EnBrace HR for Depression Treatment and Prevention in Women Trying to Conceive and Early Pregnancy
Completed · Not applicable
Conditions studied: Depressive Disorder, Pregnancy
In brief
The purpose of this study is to assess the effectiveness of the EnBrace HR prenatal supplement in preventing depression in women with a history of depression who have decided to stop taking antidepressants during their pregnancy, or treating women who are currently in a depressive episode while pregnant or planning pregnancy.
Key facts
- Study ID
- NCT02676882
- Run by
- Massachusetts General Hospital
- People needed
- 25
- Starts
- 2017-01-24
- Expected to finish
- 2018-11-30
- Last updated by the study team
- 2019-09-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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