Massachusetts General Hospital in Boston is recruiting subjects for a Phase III trial comparing the effectiveness of supplementation with two natural compounds commonly found in fish oils for treatment of major depression. Results will be measured in terms of subjects' scores on a depression rating scale over the course of the study.
The large trial, which will enroll 300 patients overall, is titled “Safety and effectiveness of Omega-3 Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression” (ClinicalTrials.gov Indentifier NCT00361374). This trial is sponsored by Mass General's Depression Clinical Research Program – an international leader in cutting edge depression research and treatment "with a focus on testing novel antidepressant treatments" – under principal investigator David Mischoulon, MD, PhD.
The present trial follows on the heels of a smaller Phase III trial of the Omega-3 fatty acid Ethyl-EPA for treating depression – results of which have yet to be published. That study was also conducted at Mass General under Dr. Mischoulon, and was sponsored by the National Center for Complementary and Alternative Medicine (NCCAM).
It is believed that a deficiency in the two natural Omega-3 compounds involved – eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) – “may lead to the development of major depression,” the researchers note. The purpose of the trial: to determine whether and how Omega-3 supplementation "can be used safely and effectively to treat major depression."
Study Length and Design
The present interventional treatment trial will involve patient visits for screening and baseline measurements, plus four more visits (every two weeks for a period of eight weeks) for testing and scoring on a depression rating scale.
The trial is a “randomized, double-blind, placebo controlled, parallel assignment, safety/efficacy study.” Specifically:
n Qualifying participants will be randomized, or chosen by chance, to enter into one of three groups.
n People in the first group will take 1 gram per day of EPA omega-3 fatty acid.
n Those in the second group will take 1 gram per day of DHA omega-3 fatty acid.
n Those in the third group will take a placebo, or fake dose.
n Because the study is “double-blind,” neither the participant, nor the doctor, nor the research staff will know which group each person is in.
n But at the end of the study all participants will be offered three months of follow-up care in the Depression Clinical Research Program.
Applicants may be male or female, and any age between 18 and 80. They must meet the study criteria for current “Major Depressive Disorder.”
Exclusion Factors Include
n Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease.
n History of seizure disorder.
n Substance use disorders, including alcohol, active within the last six months (past history is OK).
n History of multiple adverse drug reactions or allergy to the study compounds.
For More Information and to Apply, Contact
Juliana A Smith, BA
Depression Clinical Research Program
Massachusetts General Hospital, Boston
Phone: (617) 724-2936 E-mail: email@example.com
Refer to the study by ClinicalTrials.gov identifier NCT00361374
Official Title: Omega-3 Fatty Acids for Treatment of Major Depression: Differential Effects of EPA and DHA, and Associated Biochemical and Immune Parameters.
Study ID Numbers: 2005P002337; 1 RO1 MH74085-01A1
Health Authority: US Institutional Review Board; US Food and Drug Administration
About the Mass General Depression Clinical Research Program
For more information on the DCRP, go to http://www.massgeneral.org/allpsych/depression/about_us.html
To quote this site: "The DCRP is currently conducting cutting edge research in the area of depression, with a focus on testing novel antidepressant treatments and on developing new tools to understand the biological changes that occur in this condition. The successes of the Program in the area of depression have not only informed clinical practice, but in many cases have defined it for the field. The Program has gathered together over the years a large group of experienced researchers as well as promising young trainees and junior faculty, generating countless clinical reports, pilot studies, and large controlled trials. The staff at the DCRP have successfully obtained significant funding from both the National Institute of Mental Health and industry sources. Currently, there are more than 30 ongoing studies at the DCRP.
"In addition to carrying out significant research activities, the DCRP is involved in delivering excellent clinical care through the Outpatient Psychiatry Division at MG."
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