The Effect of Methylated Vitamin B Complex on Depression

Completed · Not applicable · Has a placebo group

Conditions studied: Depression

In brief

The proposed study is a 60-day, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of a methylated vitamin B complex nutritional supplement (Max Stress B™) for improving depressive and anxiety symptoms according to the Beck Depression and Anxiety Inventories, respectively, in 60 patients (18+ years of age) diagnosed with major depression or other forms of depressive disorders and an elevated level of homocysteine (\> 10 µmol/L) at baseline. Secondary outcomes will include anthropometrics for body composition, blood pressure and pulse, level of physical activity, dietary intake, and quality of life. Participants will be assessed at baseline and 30 and 60 days. The study will consist of two treatment arms: (a) vitamin B complex nutritional supplement and (b) placebo. The information obtained in this study will help in determining the efficacy of using nutritional supplements for improving the outcomes of people with depression.

Key facts

Study ID

NCT01672372

Run by

University of Miami

People needed

60

Starts

2011-01-01

Expected to finish

2011-10-01

Last updated by the study team

2014-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ages 18 years and over.
• Individuals with a diagnosed type or form of depression.
• An elevated level of homocysteine (> 10 µmol/L) at screening.
• Interest in participating in a novel nutritional supplement program.
• Willingness to follow recommendations, including going off of all medication for depression 2 weeks before starting vitamin B complex regimen.

You may not qualify if…

• Excluded in any of the above criteria are not met.

Where it is running

• University of Miami CRB — Miami, Florida, United States

Full record on ClinicalTrials.gov

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