N/A
Completed N=20
EnBrace HR for Depression Treatment and Prevention in Women Trying to Conceive and Early Pregnancy
Source: ClinicalTrials.gov NCT02676882 ↗Enrolled (actual)
20
Serious AEs
5.3%
Results posted
Sep 2019
Primary outcomePrimary: Number of Participants in the Relapse-Prevention Group (Group 1) Experiencing a Major Depressive Episode Relapse — 3 Participants — p=0.005
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in the Relapse-Prevention Group (Group 1) Experiencing a Major Depressive Episode Relapse |
3 | 0.005 sig |
| PRIMARY Rate of Treatment Response Among Depressed Participants (Group 2) to EnBrace Therapy Measured Using the Montgomery Asberg Depression Rating Scale |
5 | 0.001 sig |
Eligibility Criteria
Inclusion Criteria
Group 1 (Observational, not-randomized)
Inclusion Criteria
- Planning pregnancy or pregnant 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
Data sourced from ClinicalTrials.gov (NCT02676882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.