- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00517036
Omega-3 Fatty Acids for Treating Adults With Major Depression
Omega-3 Fatty Acids for Treatment of Major Depression: Differential Effects of EPA and DHA, and Associated Biochemical and Immune Parameters
Study Overview
Status
Conditions
Detailed Description
Major depression is a common mental disorder that affects millions of people each year. It can severely impact a person's life, causing someone to often feel sad and hopeless, as well as affect a person's sleep patterns, concentration, and energy levels. Despite the availability of numerous therapies, current treatments are not ideal for some people. Recently, some research has shown that an increase in dietary intake of polyunsaturated fatty acids (PUFAs), such as omega-3 fatty acid, might help treat depression. Eicosapentanoic acid (EPA) and docosahexanoic acid (DHA) are two common types of PUFAs high in omega-3 fatty acids and are available in low dosages in some dietary supplements. The purpose of this study is to compare the effectiveness of an EPA-enriched mixture versus pure DHA versus a placebo in treating the symptoms of major depression.
Participants in this double blind study will be randomly assigned to one of three study groups. Participants assigned to the first study group will receive capsules containing 500 mg of an EPA-enriched omega-3 fatty acid preparation. Participants assigned to the second study group will receive capsules containing 500 mg of pure DHA. Participants assigned to the third study group will receive capsules containing a placebo. The study will last approximately 9 weeks. This will include an initial screening the first week followed by an 8-week period during which all participants will take two capsules of their assigned treatment each morning. Participants will attend a total of six study visits. The initial visit will last approximately 2 hours and will include a psychiatric assessment, urine and blood collection, an electrocardiogram (EKG), and a Food Processor Questionnaire. Participants who qualify for further participation will then enter a 1-week washout period during which they will stop taking any current psychotropic medication. At the second study visit, participants will be assigned to their treatment group. Upon starting assigned treatments, participants will then return for study visits every 2 weeks to report any possible side effects and to complete standard psychiatric assessment tests. All of these study visits will take approximately 1 hour, except the last, which will take 2 hours. In addition to the psychiatric assessment and review of side effects, the final study visit will also include a physical exam and blood collection.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Meets DSM-IV diagnostic criteria for major depressive disorder
- A Clinical Global Impression-Severity (CGI-S) score greater than 3
- A Baseline Hamilton-D-17 (HAM-D-17) (Hamilton, 1960,1967) score of ³ 15
- Willing to use effective forms of contraception
Exclusion Criteria:
- Pregnant
- Suicidal or homicidal
- Serious or unstable medical illness, including cardiovascular, liver, kidney, respiratory, endocrine, neuralgic, or blood disease
- History of seizure disorder
- History of organic mental disorders, substance abuse, schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, or other psychotic disorders
- History of inflammatory or auto-immune disorder (e.g., rheumatoid arthritis, multiple sclerosis, or cancer
- History of multiple adverse drug reactions or an allergy to the study drugs
- Mood-congruent or mood-incongruent psychotic features
- Current use of other psychotropic drugs
- Clinical or laboratory evidence of hypothyroidism
- Failed to respond during the course of current major depressive episode to at least one adequate antidepressant trial, defined as 6 weeks or more of treatment with 40 mg/day of citalopram (or its antidepressant equivalent)
- Received electroconvulsive therapy (ECT) within 6 months of study entry
- Currently taking supplements enriched with omega-3 fatty acids (e.g., flax seed oil) or has taken at least 1 g/day of omega-3 fatty acids
- Consuming a diet that contains more than 3g/day of omega-3 fatty acids at study entry
- Taking anticoagulants or history of a bleeding disorder
- Patients who are currently in psychotherapy that was initiated within 90 days prior to the study screening visit.
- Current infection
- Use of systematic corticosteroid or steroid antagonists or other immunosuppressant agents (e.g., cyclosporine, interferon)
- Smokes more than 10 cigarettes per day
- Taking a vitamin E supplement greater than 400 IU
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: A
Participants will take EPA
|
1 gram per day of an EPA-enriched mixture for 8 weeks
|
EXPERIMENTAL: B
Participants will take DHA
|
1 gram per day of pure DHA for 8 weeks
|
PLACEBO_COMPARATOR: C
Participants will take placebo
|
1 gram per day of an inactive substance for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Depression rating scale score on HAM-D 17, SCID Mood Module
Time Frame: Both measured at Week 8
|
Both measured at Week 8
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark H. Rapaport, MD, Emory University
Publications and helpful links
General Publications
- Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
- Mischoulon D, Nierenberg AA, Schettler PJ, Kinkead BL, Fehling K, Martinson MA, Hyman Rapaport M. A double-blind, randomized controlled clinical trial comparing eicosapentaenoic acid versus docosahexaenoic acid for depression. J Clin Psychiatry. 2015 Jan;76(1):54-61. doi: 10.4088/JCP.14m08986.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH073765 (NIH)
- DATR A5-ETMA (Other Identifier: NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on EPA omega-3 fatty acid
-
British Columbia Cancer AgencyLotte & John Hecht Memorial FoundationUnknown
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedBreast Neoplasms | ArthralgiaUnited States
-
Medical Center AlkmaarCompleted
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH); Cedars-Sinai Medical CenterCompletedMajor Depressive DisorderUnited States
-
Karadeniz Technical UniversityUnknown
-
Haukeland University HospitalUniversity of Oslo; University of BergenCompletedCardiovascular Disease
-
Thomas Jefferson UniversityGlaxoSmithKline; Drexel UniversityUnknownQuality of Life | Inflammation | Sickle Cell Disease | HEMOGLOBIN SS | Hemoglobin S Beta-0 ThalassemiaUnited States
-
Massachusetts General HospitalEmory UniversityCompletedInflammation | Overweight | Major Depressive DisorderUnited States
-
Penn State UniversityUnited States Department of Agriculture (USDA)CompletedInflammation | Cardiovascular DiseaseUnited States
-
Mayo ClinicCompletedObesity | Barrett's EsophagusUnited States