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The Effect of Methylated Vitamin B Complex on Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01672372
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : August 6, 2014
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Information provided by (Responsible Party):
John E. Lewis, University of Miami

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Depression Dietary Supplement: Max Stress B Dietary Supplement: Placebo Max Stress B Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Methylated Vitamin B Complex on Depression
Study Start Date : January 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Max Stress B
oil/water emulsion with food coloring to simulate actual product
Dietary Supplement: Placebo Max Stress B
Experimental: Max Stress B
whole-nutrient natural source extract from probiotic colonies that contains vitamins B1, B2, B5, B6, B12, and folate, PABA, biotin, inositol, purified water and certified organic alcohol.
Dietary Supplement: Max Stress B
Participants are to mix one vial per day of either placebo or actual supplement in 1 liter of water and drink over the course of the day

Primary Outcome Measures :
  1. Depression level [ Time Frame: 2 months ]

    Assessed by the Beck Depression Inventory II, the Beck Anxiety Inventory, SF-36v2™ Health Survey, physiological and anthropometric measures

    Because item 9 of the Beck Depression Inventory inquires about "Suicidal thoughts or wishes," we will immediately notify the attending physician in the Crisis facility of UM/JMH if a subject responds affirmatively to this question, which may be indicative of suicidal ideation (SI).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01672372

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United States, Florida
University of Miami CRB
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Premier Research Labs
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Principal Investigator: John E Lewis, PhD University of Miami
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Responsible Party: John E. Lewis, Associate Professor, University of Miami Identifier: NCT01672372    
Other Study ID Numbers: 20091119
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders