A Study of 6(S)-5-MTHF Among Serotonin Reuptake Inhibitor(SSRI)-Resistant Outpatients With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to test whether oral 6(S)-5-MTHF (Deplin®) is safe and effective
      in relieving depression when it is added to standard kinds of antidepressants called
      serotonin reuptake inhibitors (SSRIs).
    

Detailed description: 
      The study consists of two sequential phases, each lasting a total of four weeks (8 weeks
      total), with visits every 10 days. Once patients agree to participate in the study by signing
      the informed consent document, a full medical and psychiatric history will be taken and a
      physical examination and blood draw will be performed. Screen rating scales will be
      performed. Screened and eligible patients will be asked to return two weeks later for a
      baseline visit when they will be randomized to double-blind treatment with placebo or Deplin
      (6(S)-5-MTHF). The double-blind treatment will last 60 days, during which patients will be
      seen every 10 days. Subjects will be randomized to one of three treatment groups:
      a)Deplin/Deplin, b) placebo/Deplin, c) placebo/placebo. Patients will have a greater than 50%
      chance of receiving active medication (Deplin) at some point in the 8 week study

        -  For patients randomly assigned to the Deplin/Deplin sequence, the dose of 6(S)-5-MTHF
           will be 7.5 mg/day during the first phase of the study, and 15 mg/d during the second
           phase of the study.

        -  For patients randomly assigned to the placebo/Deplin sequence, the dose of 6(S)-5-MTHF
           will be 7.5 mg/day during the second phase of the study.

        -  For patients randomly assigned to the placebo/placebo sequence, both tablets of study
           medication will be placebo during both phases of the study.

      All patients will be asked to take two tablets of blinded study medication in the morning, in
      addition to their stable dose of ongoing SSRI treatment. Each study medication tablet will be
      either 7.5 mg of 6(S)-5-MTHF or matching placebo.
    

Intervention name(s): 6(S)-5-MTHF (a Medical Food)
Intervention type(s): Other
Intervention description(s): The study consists of 8 visits over a period of 8 weeks or 60 days. Eligible participants will be randomized to double-blind treatment with placebo or Deplin (6(S)-5-MTHF). Participants will have a greater than 50% chance of receiving active medication (Deplin) at some point in the 8 week study. At the end of the double-blind phase, both responders and non-responders who have completed the 8 week study will have the option of receiving free, open-label adjunctive treatment with either 7.5 mg or 15 mg of 6(S)-5-MTHF for 12 months. Subjects who agree to receive open-label treatment with 6(S)-5-MTHF for 12 months will be assessed every three (3) months until the end of the follow-up phase.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment