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Trial record 73 of 2811 for:    Rating | "Depressive Disorder"

The Use Of L-Methylfolate As A Treatment For Depression

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ClinicalTrials.gov Identifier: NCT02133898
Recruitment Status : Recruiting
First Posted : May 8, 2014
Last Update Posted : May 10, 2018
Sponsor:
Collaborator:
Pamlab, Inc.
Information provided by (Responsible Party):
University of Florida

Brief 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

Condition or disease Intervention/treatment Phase
Depression Other: L-methylfolate Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Use Of A Genetic Marker To Predict Response To L-Methylfolate As A Treatment For Depression
Study Start Date : February 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
L-methyfolate
Single-arm open label administration of L-methylfolate 15mg once daily for 90 days
Other: L-methylfolate
L-methylfolate, an FDA approved medical food will be administered in 15 mg capsule form once daily for 90 days
Other Name: Deplin




Primary Outcome Measures :
  1. Hamilton Depression Rating Scale-24 [ Time Frame: Week 12 ]
    Clinician-administered questionnaire designed to assess the severity of depression in adults. It has been considered the gold standard for rating depression in clinical research.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Major Depressive Disorder based on Structured Clinical Interview for DSM-IV (SCID)
  • Hamilton Depression Rating Scale-24 (HRSD-24) score of 8-24.
  • No antidepressant medication in past 3 months

Exclusion Criteria:

  • Pregnancy/Breastfeeding/Reproductive age female not using contraception
  • Schizophrenia or other psychotic disorders
  • Bipolar Disorder
  • Cluster B personality disorder
  • Electroconvulsive Therapy (ECT) failure in past
  • Concurrent ECT or repetitive transcranial magnetic stimulation (rTMS)
  • Active substance abuse within past 6 months
  • Use of antiepileptics
  • Thyroid Stimulating Hormone (TSH) greater than 4
  • Untreated Vitamin B12 deficiency (Vitamin B12 less than 400)
  • Neurodegenerative disease or dementia (Mini Mental Status Examination (MMSE) less than or equal to 24)
  • Suicidal ideation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133898


Contacts
Contact: Herbert Ward, M.D. 352-265-7041 hward@ufl.edu
Contact: Dana Mason, B.S. 352-273-8540 dmason@ufl.edu

Locations
United States, Florida
Shands Hospital Room HD-G-17 Recruiting
Gainesville, Florida, United States, 32610
Contact: Herbert Ward, M.D.    352-265-7041    hward@ufl.edu   
Contact: Dana Mason, M.D.    352-273-8540    dmason@ufl.edu   
Principal Investigator: Herbert Ward, M.D.         
Sponsors and Collaborators
University of Florida
Pamlab, Inc.
Investigators
Principal Investigator: Herbert Ward, M.D. University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02133898     History of Changes
Other Study ID Numbers: IRB201400170
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Keywords provided by University of Florida:
Depression
MTHFR
L-methylfolate

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Tetrahydrofolates
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs