The Use Of L-Methylfolate As A Treatment For Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This is an open-label study assessing the efficacy of l-methylfolate as monotherapy in
      patients with mild to moderate major depressive disorder (MDD). The plan is to enroll 75
      patients with mild to moderate MDD based on the Structured Clinical Interview for DSM-IV
      (SCID) that have a Hamilton Depression Rating Scale-24 (HDRS-24) score between 8-24. The
      investigators will collect genotype data on methylenetetrahydrofolate Reductase (MTHFR), MTR
      and MTRR in this patient population. Subjects will be able to receive their genotype results,
      on request, upon completion of the study. The investigators hypothesize that depressed
      patients will be more likely to have a mutation in the MTHFR gene
    

Detailed description: 
      Participation in the study will consist of the following visits and test:

      Screening Visit will include being interviewed by a staff member to determine qualification.
      This interview will involve a thorough diagnostic interview that asks about different
      psychological feelings and It will also involve several rating scales that ask about
      depression, anxiety, obsessive compulsive disorder (OCD), and suicidality. The following
      scales will be conducted at this visit:

      Structured Clinical Interview for Diagnostic and Statistical Manual for Mental Disorders-IV
      (DSM) (SCID-I) is a clinician-administered, semi-structured diagnostic interview for mental
      health disorders.

      Hamilton Depression Rating Scale-24 (HAM-D) is a clinician-administered questionnaire
      designed to assess the severity of depression in adults.

      Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered questionnaire which
      assesses the severity of symptoms of anxiety.

      Yale-Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered questionnaire to
      assess the severity of symptoms of obsessive compulsive disorder.

      The Montreal Cognitive Assessment (MoCA) is a clinician administered cognitive screening tool
      to aid in the detection of mild cognitive impairment.

      The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician-administered rating scale
      that quantifies the presence and severity of suicidal ideation and behavior.

      Clinical Global Impression-Severity (CGI-S) is a 7-point clinician rating of severity of
      psychopathology.

      Next, a physician will conduct a brief medical physical exam which includes: measuring blood
      pressure, pulse, and body weight, a current and past medical history and blood will be drawn.
      If you are a female of childbearing potential, a urine pregnancy test will be performed.

      Baseline Visit The results of the laboratory tests performed at the screening visit will be
      reviewed. If eligibility is met, vital signs (blood pressure, heart rate, and weight) will be
      measured. Then a member of the research team will ask questions about current symptoms. The
      following scales will be conducted at this visit and at all remaining visits in the study:
      HAM-D, HAM-A, YBOCS, MoCA, C-SSRS, and the CGI-S.

      Clinical Global Impression-Improvement (CGI-I) is a 7-point rating of treatment response
      anchored by 1 ("very much improved) and 7 ("very much worse").

      Blood will be collected including a sample for genetic testing. Then the first week of study
      drug and instructions on how to take it will be given. Please bring any unused study drug to
      on the next visit.

      Visits 1/End of Week 1, 2/End of Week 2, 3/End of Week 4, 4/End of Week 8, 5/End of Week 12
      Vital signs will be measured and a member of the research team will ask questions about
      current symptoms. Rating scales will be conducted assessing the symptoms.

      Any unused study drug from the last visit will be collected and counted. The study doctor
      will ask about overall health and wellbeing. Please tell the study doctor about any problems
      encountered during the study. The next week's study drug will be given. Please bring any
      unused study drug to on the next visit.

      Additional blood will be collected at visit 5.
    

Intervention name(s): L-methylfolate
Intervention type(s): Other
Intervention description(s): L-methylfolate, an FDA approved medical food will be administered in 15 mg capsule form once daily for 90 days
Other intervention name(s): Deplin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Depression; MTHFR; L-methylfolate