Trial Outcomes & Findings for Omega-3 for Peri- and Postmenopausal Depression (NCT NCT00825994)
NCT ID: NCT00825994
Last Updated: 2014-08-21
Results Overview
The instrument used to measure mood at each visit was the Montgomery-Åsberg Depression Rating Scale (MADRS). The MADRS is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden).
COMPLETED
NA
31 participants
8 weeks
2014-08-21
Participant Flow
Of the 31 participants who consented at V1, 7 were ineligible at this visit. The remaining 24 were given a 1-week single-blind placebo lead-in. Women who met criteria for placebo response, defined as a \>= 50% decrease in MADRS (Montgomery-Asberg Depression Rating Scale) from screening to end of the run-in phase, were excluded from the study.
Participant milestones
| Measure |
Omega-3
omega-3 fatty acids, 2g qd \[every day\] (2 x 1 gram tablets), PO \[by mouth\]
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Omega-3
omega-3 fatty acids, 2g qd \[every day\] (2 x 1 gram tablets), PO \[by mouth\]
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Placebo Responder at V2
|
1
|
Baseline Characteristics
Omega-3 for Peri- and Postmenopausal Depression
Baseline characteristics by cohort
| Measure |
Omega-3
n=24 Participants
omega-3 fatty acids, 2g qd (2 x 1 gram tablets), PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 4.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
|
Marital Status
Married/living with partner
|
8 participants
n=99 Participants
|
|
Marital Status
Single (never married)
|
6 participants
n=99 Participants
|
|
Marital Status
Widowed/divorced
|
10 participants
n=99 Participants
|
|
Employment Status
Full-time
|
12 participants
n=99 Participants
|
|
Employment Status
Part-time
|
3 participants
n=99 Participants
|
|
Employment Status
Homemaker
|
2 participants
n=99 Participants
|
|
Employment Status
Student
|
1 participants
n=99 Participants
|
|
Employment Status
Disabled
|
1 participants
n=99 Participants
|
|
Employment Status
Unemployed
|
3 participants
n=99 Participants
|
|
Employment Status
Retired
|
1 participants
n=99 Participants
|
|
Employment Status
Other
|
1 participants
n=99 Participants
|
|
Education
Attended graduate school
|
5 participants
n=99 Participants
|
|
Education
College graduate
|
5 participants
n=99 Participants
|
|
Education
Attended some college
|
11 participants
n=99 Participants
|
|
Education
High school diploma or GED
|
2 participants
n=99 Participants
|
|
Education
Unknown
|
1 participants
n=99 Participants
|
|
Menopause Status
Perimenopausal
|
9 participants
n=99 Participants
|
|
Menopause Status
Naturally Postmenopausal
|
13 participants
n=99 Participants
|
|
Menopause Status
Surgically Postmenopausal
|
2 participants
n=99 Participants
|
|
History of previous major depressive episode
Yes
|
8 participants
n=99 Participants
|
|
History of previous major depressive episode
No
|
15 participants
n=99 Participants
|
|
History of previous major depressive episode
No answer
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Of 31 women who consented to participate per protocol 24 were eligible. Of these 24 eligible participants, three women withdrew and one was a placebo responder. 20 women started omega-3 fatty acid treatment and 19 completed the study.
The instrument used to measure mood at each visit was the Montgomery-Åsberg Depression Rating Scale (MADRS). The MADRS is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden).
Outcome measures
| Measure |
Omega-3 Fatty Acids
n=20 Participants
We conducted an open label study of omega-3 fatty acids for the treatment of major depressive disorder (MDD) in women who were perimenopausal or postmenopausal.
|
|---|---|
|
Change in MADRS Score
|
12.0 units on a scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Of 31 women who consented to participate per protocol 24 were eligible. Of these 24 eligible participants, three women withdrew and one was a placebo responder. 20 women started omega-3 fatty acid treatment and 19 completed the study. Of these 20, 15 women had hot flashes at baseline and could be included in the hot flash analysis.
Vasomotor symptoms (hot flashes) were tracked by using a self-report Hot Flash Related Daily Interference Scale (HFRDIS). The HFRDIS is a 10-item self-report questionnaire in which subjects rate the degree to which hot flashes interfere with daily activities and quality-of-life during the prior week. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total score range of 0-100 (higher score indicates greater symptom burden/interference).
Outcome measures
| Measure |
Omega-3 Fatty Acids
n=15 Participants
We conducted an open label study of omega-3 fatty acids for the treatment of major depressive disorder (MDD) in women who were perimenopausal or postmenopausal.
|
|---|---|
|
Change in Hot Flash Daily Interference Scale (HFRDIS)
|
18.5 units on a scale
Standard Deviation 27.8
|
Adverse Events
Omega-3
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omega-3
n=24 participants at risk
omega-3 fatty acids, 2g qd (2 x 1 gram tablets), PO
|
|---|---|
|
Gastrointestinal disorders
Gas and/or bloating
|
12.5%
3/24 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place