Major Depressive Disorder Clinical Trial
Official title:
A Double-Blind, Placebo Controlled Study of 6(S)-5-MTHF Among SSRI-Resistant Outpatients With Major Depressive Disorder (MDD)
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).
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.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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