A Study of 6(S)-5-MTHF Among Serotonin Reuptake Inhibitor(SSRI)-Resistant Outpatients With Major Depressive Disorder (MDD)
A Double-Blind, Placebo Controlled Study of 6(S)-5-MTHF Among SSRI-Resistant Outpatients With Major Depressive Disorder (MDD)
1 other identifier
interventional
150
1 country
11
Brief Summary
The purpose of the study is to test whether oral 6(S)-5-MTHF (Deplin®) is safe and effective in relieving depression when it is added to standard kinds of antidepressants called serotonin reuptake inhibitors (SSRIs).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 major-depressive-disorder
Started Nov 2006
Typical duration for phase_4 major-depressive-disorder
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJune 8, 2010
June 1, 2010
1.8 years
May 1, 2006
June 7, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
HAM-D
every visit
Secondary Outcomes (1)
QIDS-SR
every visit
Study Arms (3)
1
EXPERIMENTALDeplin/Deplin = participants will receive 7.5 mg/day of Deplin (6(S)-5-MTHF)for the first 4 weeks, and then 15 mg/day of Deplin for the next 4 weeks.
2
EXPERIMENTALplacebo/Deplin = participants will receive placebo for the first 4 weeks, and then 7.5 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
3
PLACEBO COMPARATORplacebo/placebo = both tablets of study medication will be placebo during both phases of the study.
Interventions
The study consists of 8 visits over a period of 8 weeks or 60 days. Eligible participants will be randomized to double-blind treatment with placebo or Deplin (6(S)-5-MTHF). Participants will have a greater than 50% chance of receiving active medication (Deplin) at some point in the 8 week study. At the end of the double-blind phase, both responders and non-responders who have completed the 8 week study will have the option of receiving free, open-label adjunctive treatment with either 7.5 mg or 15 mg of 6(S)-5-MTHF for 12 months. Subjects who agree to receive open-label treatment with 6(S)-5-MTHF for 12 months will be assessed every three (3) months until the end of the follow-up phase.
Eligibility Criteria
You may qualify if:
- years old
- Meet criteria for current Major Depressive Disorder
- Currently taking an SSRI
You may not qualify if:
- Pregnant women
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
- Prior course of MTHF augmentation, or intolerance to MTHF at any dose
- substance use disorders active within the last six months, any bipolar disorder (current or past), or any psychotic disorder (current or past).
- Have failed more than 2 adequate antidepressant trials during the current Major Depressive Episode.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Pamlab, L.L.C.collaborator
Study Sites (11)
University of California San Diego School of Medicine
San Diego, California, 92161, United States
Rush University Medical Center, Psychiatric Medicine Associates, LLC
Chicago, Illinois, 60612, United States
Lousiana State University Health Sciences Center
New Orleans, Louisiana, 70115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Burlington Medical Associates
Burlington, Massachusetts, 01803, United States
Waltham Family Practice
Waltham, Massachusetts, 02453, United States
Charles River Medical Associates
Westborough, Massachusetts, 01581, United States
Univeristy of Cincinnati, College of Medicine
Cincinnati, Ohio, 45267, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Southeast Health Consultants, LLC
Charleston, South Carolina, 29407, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Related Publications (2)
Zajecka JM, Fava M, Shelton RC, Barrentine LW, Young P, Papakostas GI. Long-term efficacy, safety, and tolerability of L-methylfolate calcium 15 mg as adjunctive therapy with selective serotonin reuptake inhibitors: a 12-month, open-label study following a placebo-controlled acute study. J Clin Psychiatry. 2016 May;77(5):654-60. doi: 10.4088/JCP.15m10181.
PMID: 27035404DERIVEDPapakostas GI, Shelton RC, Zajecka JM, Etemad B, Rickels K, Clain A, Baer L, Dalton ED, Sacco GR, Schoenfeld D, Pencina M, Meisner A, Bottiglieri T, Nelson E, Mischoulon D, Alpert JE, Barbee JG, Zisook S, Fava M. L-methylfolate as adjunctive therapy for SSRI-resistant major depression: results of two randomized, double-blind, parallel-sequential trials. Am J Psychiatry. 2012 Dec;169(12):1267-74. doi: 10.1176/appi.ajp.2012.11071114.
PMID: 23212058DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George I Papakostas, M.D
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 1, 2006
First Posted
May 3, 2006
Study Start
November 1, 2006
Primary Completion
August 1, 2008
Study Completion
June 1, 2010
Last Updated
June 8, 2010
Record last verified: 2010-06