DepressionNCT02133898
The Use Of L-Methylfolate As A Treatment For Depression
A study testing L-methylfolate in people with Depression, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- L-methylfolate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 4 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands Hospital Room HD-G-17
Gainesville, Florida, 32610
About this study
Official title: The Use Of A Genetic Marker To Predict Response To L-Methylfolate As A Treatment For Depression
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
Read the 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.
- Conditions
- Depression
- Being tested
- L-methylfolate
- Keywords
- Depression, MTHFR, L-methylfolate
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-methylfolateOther
Also called Deplin
L-methylfolate, an FDA approved medical food will be administered in 15 mg capsule form once daily for 90 days
| Study group | Role | What they receive |
|---|---|---|
| L-methyfolate | Other | Single-arm open label administration of L-methylfolate 15mg once daily for 90 days Receives: Other: L-methylfolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startFeb 2016
- Primary completion1 Apr 2022
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Pamlab, Inc.
- Responsible party
- Sponsor
- Investigators
- Gary Kanter, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133898
- Sponsor's protocol ID
- IRB201400170
- Status last verified
- Jun 2023
- First submitted
- 6 May 2014
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use Of A Genetic Marker To Predict Response To L-Methylfolate As A Treatment For Depression
- ClinicalTrials.gov ID
- NCT02133898
- Acronym / sponsor ID
- IRB201400170
- Conditions
- Depression
- Keywords
- Depression, MTHFR, L-methylfolate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Pamlab, Inc.
- Study start
- Feb 2016 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 8 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-methyfolate | Other | Other: L-methylfolateSingle-arm open label administration of L-methylfolate 15mg once daily for 90 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-methylfolateAlso: DeplinL-methylfolate, an FDA approved medical food will be administered in 15 mg capsule form once daily for 90 days | Other | L-methyfolate |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Kanter, M.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-methylfolate in people with Depression, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale-24 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.