Ignite Creation Date:
2024-05-06 @ 2:49 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02133898
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
2014-05-06
Brief Title:
The Use Of L-Methylfolate As A Treatment For Depression
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
The Use Of A Genetic Marker To Predict Response To L-Methylfolate As A Treatment For Depression
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 1End of Week 1 2End of Week 2 3End of Week 4 4End of Week 8 5End 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 weeks study drug will be given Please bring any unused study drug to on the next visit
Additional blood will be collected at visit 5
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 1End of Week 1 2End of Week 2 3End of Week 4 4End of Week 8 5End 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 weeks 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None