Major Depressive Disorder
Conditions
Keywords
Depression, Omega-3, Boston
Brief summary
This study examines the difference in the effectiveness of two natural compounds, eicosapentanoic (EPA) and docosahexanoic (DHA)omega-3 fatty acids, in treating major depressive disorder. Both types of omega-3 fatty acids are commonly found in fish oils. It is believed that a deficiency in these omega-3 fatty acids may lead to the development of major depression.
Detailed description
The study lasts for eight weeks and involves four visits after the screen and baseline visits (biweekly). Participants will be randomized, or chosen by chance, to enter into one of three groups. People in the first group will take 1 g/day or EPA omega-3 fatty acid, those in the second group will take 1 g/day of DHA omega-3 fatty acid, and those in the third group will take a placebo. This study is double-blind, which means that neither the participant, nor the doctor, nor the research staff will know which group each person is in. At the end of the study the participant will be offered three months of follow-up care at the Depression Clinical and Research Program.
Interventions
DIETARY_SUPPLEMENTeicosapentaenoic acid
1 gram/day
DIETARY_SUPPLEMENTdocosahexaenoic acid
1 gram/day
DRUGPlacebo
980 milligram/day
Sponsors
Cedars-Sinai Medical Center
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men or women aged 18-80 years old. * Must meet criteria for current Major Depressive Disorder.
Exclusion criteria
* Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease * History of seizure disorder. * Substance use disorders, including alcohol, active within the last six months (past history is OK). * History of multiple adverse drug reactions or allergy to the study drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on a Depression Severity Rating Scale Over Eight Weeks | 8 weeks | Change in score on 17-item Hamilton D depression severity rating scale over 8 weeks of treatment. Scores were obtained every 2 weeks for 8 weeks. The total sum score of the 17 items is used to assess depressive severity. Possible total scores range from 0-52, with a higher score indicating greater depressive severity. Scores of 7 or less are indicative of full remission (i.e. no depression). Scores of 8-15 indicate mild depression; scores of 16-25 indicate moderate depression; scores of 25 or greater indicate severe depression. Mixed model repeated measures analysis (MMRM) was used to examine treatment group effect on changes from baseline to week 8 in Hamilton D scores. Models included subjects as a random effect, and treatment group and study week as fixed effects. An auto-regressive covariance structure was used because it provided the best fit to the data. Site and baseline score were included as covariates in all models. |
Countries
United States
Participant flow
Recruitment details
196 adults with MDD were recruited from 05/18/06 to 06/30/11 at Massachusetts General Hospital and Cedars-Sinai Medical Center.
Participants by arm
| Arm | Count |
|---|---|
| Eicosapentaenoic Acid (EPA) Eicosapentaenoic acid (EPA) Omega-3, 1g/day
eicosapentaenoic acid: 1 gram/day | 60 |
| Docosahexaenoic Acid (DHA) Docosahexaenoic acid (DHA) Omega-3, 1g/day
docosahexaenoic acid: 1 gram/day | 58 |
| Placebo Placebo capsule (980mg soybean oil)
Placebo: 980 milligram/day | 59 |
| Total | 177 |
Baseline characteristics
| Characteristic | Eicosapentaenoic Acid (EPA) | Docosahexaenoic Acid (DHA) | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 8 Participants | 5 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 50 Participants | 54 Participants | 157 Participants |
| Age, Continuous | 45.8 years STANDARD_DEVIATION 12.5 | 46.2 years STANDARD_DEVIATION 11.8 | 45.0 years STANDARD_DEVIATION 12.1 | 45.8 years STANDARD_DEVIATION 12.5 |
| Region of Enrollment United States | 60 participants | 58 participants | 59 participants | 177 participants |
| Sex: Female, Male Female | 38 Participants | 32 Participants | 35 Participants | 105 Participants |
| Sex: Female, Male Male | 22 Participants | 26 Participants | 24 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 39 / 60 | 40 / 58 | 43 / 59 |
| serious Total, serious adverse events | 0 / 60 | 0 / 58 | 0 / 59 |
Outcome results
Primary
Score on a Depression Severity Rating Scale Over Eight Weeks
Change in score on 17-item Hamilton D depression severity rating scale over 8 weeks of treatment. Scores were obtained every 2 weeks for 8 weeks. The total sum score of the 17 items is used to assess depressive severity. Possible total scores range from 0-52, with a higher score indicating greater depressive severity. Scores of 7 or less are indicative of full remission (i.e. no depression). Scores of 8-15 indicate mild depression; scores of 16-25 indicate moderate depression; scores of 25 or greater indicate severe depression. Mixed model repeated measures analysis (MMRM) was used to examine treatment group effect on changes from baseline to week 8 in Hamilton D scores. Models included subjects as a random effect, and treatment group and study week as fixed effects. An auto-regressive covariance structure was used because it provided the best fit to the data. Site and baseline score were included as covariates in all models.
Time frame: 8 weeks
Population: We randomized 196 of 389 screened patients. Nineteen subjects dropped out before completing at least one post-baseline visit, leaving 177 evaluable subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eicosapentaenoic Acid (EPA) | Score on a Depression Severity Rating Scale Over Eight Weeks | -10.34 units on a scale | Standard Error 0.62 |
| Docosahexaenoic Acid (DHA) | Score on a Depression Severity Rating Scale Over Eight Weeks | -9.26 units on a scale | Standard Error 0.62 |
| Placebo | Score on a Depression Severity Rating Scale Over Eight Weeks | -9.49 units on a scale | Standard Error 0.61 |