The Use Of L-Methylfolate As A Treatment For Depression

NCT02133898 | Completed

• 1 other identifier: IRB201400170
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Conditions

Depression

Keywords

Depression; MTHFR; L-methylfolate

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale-24

  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.

  Week 12

Study Arms (1)

L-methyfolate

OTHER

Single-arm open label administration of L-methylfolate 15mg once daily for 90 days

Other: L-methylfolate

Interventions

L-methylfolate OTHER

L-methylfolate, an FDA approved medical food will be administered in 15 mg capsule form once daily for 90 days

Also known as: Deplin

L-methyfolate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Pamlab, Inc.: collaborator

Study Sites (1)

Shands Hospital Room HD-G-17

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Depression

Interventions

5-methyltetrahydrofolate

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Gary Kanter, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 8, 2014
• Study Start: February 1, 2016
• Primary Completion: April 1, 2022
• Study Completion: April 4, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

US (1)