The Effect of Methylated Vitamin B Complex on Depression

NCT01672372 | Completed DMC

• 1 other identifier: 20091119
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Depression level

  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).

  2 months

Study Arms (2)

Placebo Max Stress B

PLACEBO COMPARATOR

oil/water emulsion with food coloring to simulate actual product

Dietary Supplement: Placebo Max Stress B

Max Stress B

EXPERIMENTAL

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

Interventions

Max Stress B DIETARY_SUPPLEMENT

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

Max Stress B

Placebo Max Stress B DIETARY_SUPPLEMENT

Placebo Max Stress B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Miami: lead
• Premier Research Labs: collaborator

Study Sites (1)

University of Miami CRB

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• John E Lewis, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 24, 2012
• Study Start: January 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 6, 2014

Record last verified: 2014-08

Locations

US (1)