The Effect of Methylated Vitamin B Complex on Depression

This study has been completed.
Sponsor:
Collaborator:
Premier Research Labs
Information provided by (Responsible Party):
John E. Lewis, University of Miami
ClinicalTrials.gov Identifier:
NCT01672372
First received: August 21, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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 Intervention
Depression
Dietary Supplement: Max Stress B
Dietary Supplement: Placebo Max Stress B

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Methylated Vitamin B Complex on Depression

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Depression level [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

    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).



Enrollment: 60
Study Start Date: January 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672372

Locations
United States, Florida
University of Miami CRB
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Premier Research Labs
Investigators
Principal Investigator: John E Lewis, PhD University of Miami
  More Information

No publications provided

Responsible Party: John E. Lewis, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01672372     History of Changes
Other Study ID Numbers: 20091119
Study First Received: August 21, 2012
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Vitamin B Complex
Folic Acid
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014