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EnBrace HR for Depression Treatment and Prevention in Women Trying to Conceive and Early Pregnancy

NCT02676882 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-09-20

Study results available
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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.

Conditions

  • Depressive Disorder
  • Pregnancy

Interventions

DIETARY_SUPPLEMENT

EnBrace HR

Prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study

Sponsors & Collaborators

  • JayMac Pharmaceuticals, LLC

    collaborator UNKNOWN

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Marlene P Freeman, MD · Massachusetts General Hospital, Center for Women's Mental Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-24
Primary Completion
2018-05-15
Completion
2018-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02676882 on ClinicalTrials.gov