Trial Outcomes & Findings for EnBrace HR for Depression Treatment and Prevention in Women Trying to Conceive and Early Pregnancy (NCT NCT02676882)
NCT ID: NCT02676882
Last Updated: 2019-09-20
Results Overview
Experience a response (50% improvement in depressive symptoms) to EnBrace therapy, as assessed by the Montgomery Asberg Depression Rating Scale (MADRS). The MADRS is a 10-item scale assessing the presence and severity of depressive symptoms, each with a score of 0-6 in which 0 denotes absence of a given symptom and 6 denotes the highest burden, frequency, or severity of a given symptom. The total score (sum of 10 items) ranges from 0-60 points, with scores of \</=10 considered clinically well and scores of \>/=15 considered clinically depressed for this study. Symptoms assessed include reported and apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulty, lassitude, anhedonia, pessimistic thoughts, and suicidality.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Assessed every two weeks for 12 weeks
Results posted on
2019-09-20
Participant Flow
Recruitment period: 1/24/2017 through 3/5/2018 Recruitment methods: Medical clinics, womensmentalhealth.org, other online recruitment sources, flyers in public locations, database of previous patients and research participants at the Center for Women's Mental Health at MGH
Potential subjects were screened by phone and if eligible attended a baseline screening visit at which they consented to further eligibility assessment for each of two groups. If after consent they failed to meet eligibility criteria, they were considered enrolled per IRB guidelines, but were not assigned to a group to start study medication.
Participant milestones
| Measure |
Group 1 - Relapse-Prevention Group ("Well" Group)
Inclusion criteria: women ages 18+ who currently meet criteria for stable remission from MDD as defined by a baseline score of \< 10 on the Montgomery-Åsberg Depression Rating Scale (MADRS),have recent or current antidepressant use which they have elected to discontinue for pregnancy, have histories of an MDE as verified using the Mini-International Neuropsychiatric Interview (MINI) for DSM-IV, and have MDD as one of their primary diagnoses.
Treatment: EnBrace HR, a prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study
|
Group 2 - Treatment Group ("Depressed" Group)
Inclusion criteria: Women ages 18+ who are currently experiencing clinically significant depressive symptoms as defined by a baseline score of \> 15 on the MADRS, planning not to start an antidepressant or to increase the dose of a current antidepressant after consultation with their prescribing provider, currently experiencing an MDE as verified using the MINI, and have MDD as one of their primary diagnoses. Women who endorsed any suicidal ideation were not included in the study, and follow-up care was swiftly coordinated.
Treatment: EnBrace HR, a prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
7
|
|
Overall Study
Evaluable
|
11
|
6
|
|
Overall Study
COMPLETED
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Group 1 - Relapse-Prevention Group ("Well" Group)
Inclusion criteria: women ages 18+ who currently meet criteria for stable remission from MDD as defined by a baseline score of \< 10 on the Montgomery-Åsberg Depression Rating Scale (MADRS),have recent or current antidepressant use which they have elected to discontinue for pregnancy, have histories of an MDE as verified using the Mini-International Neuropsychiatric Interview (MINI) for DSM-IV, and have MDD as one of their primary diagnoses.
Treatment: EnBrace HR, a prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study
|
Group 2 - Treatment Group ("Depressed" Group)
Inclusion criteria: Women ages 18+ who are currently experiencing clinically significant depressive symptoms as defined by a baseline score of \> 15 on the MADRS, planning not to start an antidepressant or to increase the dose of a current antidepressant after consultation with their prescribing provider, currently experiencing an MDE as verified using the MINI, and have MDD as one of their primary diagnoses. Women who endorsed any suicidal ideation were not included in the study, and follow-up care was swiftly coordinated.
Treatment: EnBrace HR, a prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
EnBrace HR for Depression Treatment and Prevention in Women Trying to Conceive and Early Pregnancy
Baseline characteristics by cohort
| Measure |
Group 1 - Relapse-Prevention Group ("Well" Group)
n=13 Participants
Inclusion criteria: women ages 18+ who currently meet criteria for stable remission from MDD as defined by a baseline score of \< 10 on the Montgomery-Åsberg Depression Rating Scale (MADRS),have recent or current antidepressant use which they have elected to discontinue for pregnancy, have histories of an MDE as verified using the Mini-International Neuropsychiatric Interview (MINI) for DSM-IV, and have MDD as one of their primary diagnoses.
Treatment: EnBrace HR, a prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study
|
Group 2 - Treatment Group ("Depressed" Group)
n=7 Participants
Inclusion criteria: Women ages 18+ who are currently experiencing clinically significant depressive symptoms as defined by a baseline score of \> 15 on the MADRS, planning not to start an antidepressant or to increase the dose of a current antidepressant after consultation with their prescribing provider, currently experiencing an MDE as verified using the MINI, and have MDD as one of their primary diagnoses. Women who endorsed any suicidal ideation were not included in the study, and follow-up care was swiftly coordinated.
Treatment: EnBrace HR, a prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.2 years
n=5 Participants
|
35.3 years
n=7 Participants
|
32.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Mini International Neuropsychiatric Interview Major Depressive Episode Module
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Score </= 10
|
13 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) >/= 15
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed every two weeks for 12 weeksPopulation: Those women in group 1 who discontinued antidepressants (ADs) during the study (2 women of 13 in group 1 planned to discontinue ADs when they became pregnant and were actively trying to conceive, but they did not become pregnant during the trial and did not decrease the dose of their ADs).
Evidence of recurrence of major depression episode, as defined by the Mini-International Neuropsychiatric Interview (MINI) mood module and/or research clinician interview. The MINI is a brief, validated structured clinical interview used for diagnostic purposes for DSM-IV and ICD-10 psychiatric disorders in clinical trials. The interview is performed by a licensed study physician and takes about 15 minutes. The MINI is divided into modules corresponding to diagnostic categories, and questions are answered as a binary yes or no by the research subject. The MINI mood module in this case refers to the set of questions examining major depressive disorder symptoms to identify if a patient is experiencing depressive symptoms that meet criteria as a major depressive episode.
Outcome measures
| Measure |
Group 1 - Relapse-Prevention Group ("Well" Group)
n=11 Participants
Inclusion criteria: women ages 18+ who currently meet criteria for stable remission from MDD as defined by a baseline score of \< 10 on the Montgomery-Åsberg Depression Rating Scale (MADRS),have recent or current antidepressant use which they have elected to discontinue for pregnancy, have histories of an MDE as verified using the Mini-International Neuropsychiatric Interview (MINI) for DSM-IV, and have MDD as one of their primary diagnoses.
Treatment: EnBrace HR, a prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study
|
|---|---|
|
Number of Participants in the Relapse-Prevention Group (Group 1) Experiencing a Major Depressive Episode Relapse
|
3 Participants
|
PRIMARY outcome
Timeframe: Assessed every two weeks for 12 weeksPopulation: Of the 7 women eligible for inclusion in Group 2, 1 did not initiate study medication and dropped from the study after baseline. The 6 other women were evaluable as they returned for follow-up visits.
Experience a response (50% improvement in depressive symptoms) to EnBrace therapy, as assessed by the Montgomery Asberg Depression Rating Scale (MADRS). The MADRS is a 10-item scale assessing the presence and severity of depressive symptoms, each with a score of 0-6 in which 0 denotes absence of a given symptom and 6 denotes the highest burden, frequency, or severity of a given symptom. The total score (sum of 10 items) ranges from 0-60 points, with scores of \</=10 considered clinically well and scores of \>/=15 considered clinically depressed for this study. Symptoms assessed include reported and apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulty, lassitude, anhedonia, pessimistic thoughts, and suicidality.
Outcome measures
| Measure |
Group 1 - Relapse-Prevention Group ("Well" Group)
n=6 Participants
Inclusion criteria: women ages 18+ who currently meet criteria for stable remission from MDD as defined by a baseline score of \< 10 on the Montgomery-Åsberg Depression Rating Scale (MADRS),have recent or current antidepressant use which they have elected to discontinue for pregnancy, have histories of an MDE as verified using the Mini-International Neuropsychiatric Interview (MINI) for DSM-IV, and have MDD as one of their primary diagnoses.
Treatment: EnBrace HR, a prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study
|
|---|---|
|
Rate of Treatment Response Among Depressed Participants (Group 2) to EnBrace Therapy Measured Using the Montgomery Asberg Depression Rating Scale
|
5 Participants
|
Adverse Events
Group 1 - Relapse Prevention Group ("Well" Group)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 2 - Treatment Group ("Depressed" Group)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 - Relapse Prevention Group ("Well" Group)
n=13 participants at risk
Treatment: EnBrace HR - prescription folate prenatal supplement with dietary ingredients; one multiphasic gelatin capsule/day for 12 weeks.
Inclusion criteria: women ages 18+ who currently meet criteria for stable remission from Major Depressive Disorder (MDD) as defined by a baseline score of \</=10 on the Montgomery-Åsberg Depression Rating Scale (MADRS), have recent or current antidepressant use which they have elected to discontinue for pregnancy, have histories of a major depressive episode (MDE) as verified using the Mini-International Neuropsychiatric Interview (MINI) for DSM-IV, and have MDD as one of their primary diagnoses.
|
Group 2 - Treatment Group ("Depressed" Group)
n=6 participants at risk
Treatment: EnBrace HR - prescription folate prenatal supplement with dietary ingredients; one multiphasic gelatin capsule/day for 12 weeks.
Inclusion criteria: Women ages 18+ who are currently experiencing clinically significant depressive symptoms as defined by a baseline score of \>/=15 on the MADRS, planning not to start an antidepressant or to increase the dose of a current antidepressant after consultation with their prescribing provider, currently experiencing an MDE as verified using the MINI, and have MDD as one of their primary diagnoses. Women who endorsed any suicidal ideation were not included in the study, and follow-up care was swiftly coordinated.
|
|---|---|---|
|
Psychiatric disorders
major depressive episode requiring inpatient hospitalization
|
7.7%
1/13 • Number of events 1 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
0.00%
0/6 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
Other adverse events
| Measure |
Group 1 - Relapse Prevention Group ("Well" Group)
n=13 participants at risk
Treatment: EnBrace HR - prescription folate prenatal supplement with dietary ingredients; one multiphasic gelatin capsule/day for 12 weeks.
Inclusion criteria: women ages 18+ who currently meet criteria for stable remission from Major Depressive Disorder (MDD) as defined by a baseline score of \</=10 on the Montgomery-Åsberg Depression Rating Scale (MADRS), have recent or current antidepressant use which they have elected to discontinue for pregnancy, have histories of a major depressive episode (MDE) as verified using the Mini-International Neuropsychiatric Interview (MINI) for DSM-IV, and have MDD as one of their primary diagnoses.
|
Group 2 - Treatment Group ("Depressed" Group)
n=6 participants at risk
Treatment: EnBrace HR - prescription folate prenatal supplement with dietary ingredients; one multiphasic gelatin capsule/day for 12 weeks.
Inclusion criteria: Women ages 18+ who are currently experiencing clinically significant depressive symptoms as defined by a baseline score of \>/=15 on the MADRS, planning not to start an antidepressant or to increase the dose of a current antidepressant after consultation with their prescribing provider, currently experiencing an MDE as verified using the MINI, and have MDD as one of their primary diagnoses. Women who endorsed any suicidal ideation were not included in the study, and follow-up care was swiftly coordinated.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea with onset during pregnancy
|
7.7%
1/13 • Number of events 1 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
33.3%
2/6 • Number of events 2 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Gastrointestinal disorders
Constipation
|
23.1%
3/13 • Number of events 3 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
0.00%
0/6 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough and nasal congestion
|
15.4%
2/13 • Number of events 2 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
0.00%
0/6 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Psychiatric disorders
Difficulty concentrating
|
15.4%
2/13 • Number of events 2 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
0.00%
0/6 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Infections and infestations
Urinary tract infection
|
15.4%
2/13 • Number of events 2 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
0.00%
0/6 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
7.7%
1/13 • Number of events 1 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
16.7%
1/6 • Number of events 1 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Nervous system disorders
Headache
|
15.4%
2/13 • Number of events 2 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
0.00%
0/6 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
7.7%
1/13 • Number of events 1 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
0.00%
0/6 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Musculoskeletal and connective tissue disorders
Abdominal muscle ache
|
0.00%
0/13 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
16.7%
1/6 • Number of events 1 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Gastrointestinal disorders
Dysgeusia
|
7.7%
1/13 • Number of events 1 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
0.00%
0/6 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Skin and subcutaneous tissue disorders
Suspected niacin flushing
|
0.00%
0/13 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
16.7%
1/6 • Number of events 1 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Musculoskeletal and connective tissue disorders
Mechanical fall
|
0.00%
0/13 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
16.7%
1/6 • Number of events 1 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Blood and lymphatic system disorders
Mild anemia
|
0.00%
0/13 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
16.7%
1/6 • Number of events 1 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Number of events 1 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
0.00%
0/6 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Psychiatric disorders
Worsening of depression symptoms with request for treatment referral
|
0.00%
0/13 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
16.7%
1/6 • Number of events 1 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Metabolism and nutrition disorders
Mild weight gain
|
7.7%
1/13 • Number of events 1 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
0.00%
0/6 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
|
Cardiac disorders
Chest tightness
|
7.7%
1/13 • Number of events 1 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
0.00%
0/6 • Participants were followed for up to 9 months - 3 months in the treatment phase and 6 months in the optional follow-up phase.
Adverse event information was collected at each visit using a standardized adverse event reporting form and assessed by a licensed physician for severity. If a participant could not report to a visit due to a serious adverse event, this information was also recorded. If a participant was not exposed to the study medication, they were not included in the total number of participants at risk. This occurred in Group 2, in which 1 participant dropped from the study prior to medication initiation.
|
Additional Information
Dr. Marlene Freeman
Massachusetts General Hospital Center for Women's Mental Health
Phone: 617-643-6403
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place