ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 35 of 1505 for:    depression AND (woman OR women OR female)

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02676882
Recruitment Status : Recruiting
First Posted : February 8, 2016
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
JayMac Pharmaceuticals, LLC
Information provided by (Responsible Party):
Marlene P. Freeman, MD, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Pregnancy Dietary Supplement: EnBrace HR Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: EnBrace HR for Depression Treatment and Prevention in Women Trying to Conceive and Early Pregnancy
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
EnBrace HR
Prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 weeks
Dietary Supplement: EnBrace HR
Prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study



Primary Outcome Measures :
  1. Major depressive episode relapse [ Time Frame: Assessed every two weeks for 12 weeks ]
    Evidence of recurrence of major depression episode, as defined by the Mini-International Neuropsychiatric Interview (MINI) mood portion and/or research clinician interview

  2. Treatment of current depressive episode [ Time Frame: Assessed every two weeks for 12 weeks ]
    Experience a response (50% improvement in depressive symptoms) to EnBrace therapy, as assessed by various scored mood questionnaires



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Group 1 (Observational, not-randomized)

Inclusion Criteria:

  1. Planning pregnancy or pregnant < 28 weeks gestation
  2. Currently meet criteria for stable remission from MDD, defined as a baseline score of < 10 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
  3. Current or recent treatment with an AD
  4. Have elected to discontinue AD medication for pregnancy (may have already begun or completed taper)
  5. 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
  6. Has a treating prescribing clinician for the treatment of MDD

Exclusion Criteria:

  1. Current major depressive episode, as diagnosed on the MINI mood portion
  2. Significant risk for self-harm or harm to others
  3. Psychotic symptoms
  4. Meeting criteria for a primary diagnosis of schizophrenia, an active eating disorder, dementia, delirium, or other cognitive disorder
  5. Presence of an active substance and/or alcohol abuse disorder within six months prior to screening
  6. Pernicious anemia or history of gastric bypass surgery
  7. Seizure disorder and/or on anticonvulsant medications
  8. Allergy to beeswax, soy, fish, nuts, peanuts, egg, wheat, milk, and/or shellfish
  9. Non-English speaking

Group 2

Inclusion Criteria:

  1. Planning pregnancy or pregnant < 28 weeks gestation
  2. Currently experiencing clinically significant depressive symptoms, defined as a baseline score of > 15 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
  3. Experiencing a major depressive episode, as verified using the MINI Structured Clinical Interview for DSM-5; have MDD as one of their primary diagnoses
  4. Has a treating prescribing clinician for the treatment of MDD

Exclusion Criteria:

  1. Significant risk for self-harm or harm to others
  2. Psychotic symptoms
  3. Meeting criteria for a primary diagnosis of schizophrenia, an active eating disorder, dementia, delirium, or other cognitive disorder
  4. Presence of an active substance and/or alcohol abuse disorder within six months prior to screening
  5. Pernicious anemia or history of gastric bypass surgery
  6. Seizure disorder and/or on anticonvulsant medications
  7. Allergy to beeswax, soy, fish, nuts, peanuts, egg, wheat, milk, and/or shellfish
  8. Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676882


Contacts
Contact: Olivia Noe, BS (617)726-2912 onoe@partners.org
Contact: Taylor Church, BS 617-643-9284 tchurch1@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Olivia Noe, BS    617-726-2912    onoe@partners.org   
Contact: Taylor Church, BS       tchurch1@partners.org   
Sub-Investigator: Lee S Cohen, MD         
Principal Investigator: Marlene F Freeman, MD         
Sponsors and Collaborators
Massachusetts General Hospital
JayMac Pharmaceuticals, LLC
Investigators
Principal Investigator: Marlene P Freeman, MD Massachusetts General Hospital, Center for Women's Mental Health

Responsible Party: Marlene P. Freeman, MD, Associate Director, Center for Women's Mental Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02676882     History of Changes
Other Study ID Numbers: 2016P000275
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be presented in aggregate to protect participant privacy.

Keywords provided by Marlene P. Freeman, MD, Massachusetts General Hospital:
Depressive Disorder
Depression
Antidepressants
Pregnancy
Folate
Dietary Supplements
Omega-3 Fatty Acids
Women's Health
Vitamins

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders