The Effect of Methylated Vitamin B Complex on Depression

Study Design Potential participants will be identified through referrals from the offices of Dr. Woolger, the UM Department of Psychiatry Clinics, the Medical Wellness Center, and the Center for Complementary and Integrative Medicine. Drs. Woolger and Konefal will conduct a preliminary screening of their clients to determine if the potential participant meets the inclusion criteria to participate in the study. Dr. Lewis, Messrs. Long, Dicenso, or Bregman, or Mses. Hoffman, Rafatjah, Melillo, Ko, Alonso, or McCurdy will conduct preliminary screenings through the Medical Wellness Center or the Center for Complementary and Integrative Medicine. Once accepted into the study, participants will then contact Dr. Lewis, Messrs. Long, Dicenso, or Bregman, or Mses. Hoffman, Rafatjah, Melillo, Ko, Alonso, or McCurdy for informed consent and study protocol procedures. Subjects will then be assigned to one of the two study conditions. Assignment of subjects to treatment groups will be done by following a table of random permutations, which will balance the number of subjects in each group. The table will be prepared in advance by a random number generating program.

Participants Sixty subjects (30 in each condition) with depression will participate in this study. Subjects will be primarily those who have expressed an interest in trying non-medication or integrative treatment approaches for their depression.

Initial visit The study will be fully explained to each potential participant, and a written informed consent will be obtained before beginning the intervention. Dr. Lewis, Messrs. Long, Dicenso, or Bregman, or Mses. Hoffman, Rafatjah, Melillo, Ko, Alonso, or McCurdy will administer all of the assessments at baseline and follow-up and will notify the subjects of the time to return for the follow-up appointments.

Intervention Participants enrolled in the study will receive either the Max Stress B™ at a dosage level of ½ teaspoon twice daily or the placebo for the 60-day treatment period. Subjects will not be advised to modify eating or physical activity habits or non-depression prescription medication use. Subjects will not be allowed to use depression-treatment medication starting at 2 weeks before beginning the intervention and until the conclusion of the 60-day treatment period. Subjects will be instructed not to consume any other nutritional supplements containing any of the vitamin B complex nutrients, SAMe, inositol, PABA, or folate for two weeks prior to having the baseline assessments and until the conclusion of the 60-day period. Because of how Max Stress B™ is produced by Premier Research Labs, consuming the Max Stress B™ should be well-tolerated. We are aware of no side effects of this particular product. According to the company's literature, Max Stress B™ is a whole-nutrient natural source extract from probiotic colonies that contains: vitamins B1, B2, B3, B5, B6, and B12, and folate, PABA, biotin, inositol, purified water, and certified organic alcohol. This product is documented online at the following web address: http://www.prlabs.com/ under the "Products" tab, item #2352.

Outcomes and Assessments Each participant will complete a basic demographics and medical history questionnaire to assess the importance of these background variables. They will also be asked to list their current medications and note any changes in type or amount during the course of the study. Blood pressure, heart rate, body weight and height, skinfold assessments, and hip and waist circumference will be assessed by Dr. Lewis, Messrs. Long, Dicenso, Bregman, or Reihm, or Mses. Rafatjah, Melillo, Ko, Alonso, or McCurdy at baseline and 30- and 60-days follow-up.