A Study of 6(S)-5-MTHF Among Serotonin Reuptake Inhibitor(SSRI)-Resistant Outpatients With Major Depressive Disorder (MDD) - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital Pamlab, L.L.C.
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00321152

Purpose

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).

Condition	Intervention	Phase
Major Depressive Disorder	Drug: 6(S)-5-MTHF	Phase III

MedlinePlus related topics: Depression

Drug Information available for: Serotonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title:	A Double-Blind, Placebo Controlled Study of 6(S)-5-MTHF Among SSRI-Resistant Outpatients With Major Depressive Disorder (MDD)

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

HAM-D [ Time Frame: every visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

QIDS-SR [ Time Frame: every visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental drug/drug = 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.	Drug: 6(S)-5-MTHF 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 (drug name: 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.
2: Experimental placebo/drug = 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.	Drug: 6(S)-5-MTHF 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 (drug name: 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.
3: Placebo Comparator placebo/placebo = both tablets of study medication will be placebo during both phases of the study.	Drug: 6(S)-5-MTHF 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 (drug name: 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.

Detailed Description:

The study consists of two sequential phases, each lasting a total of four weeks (8 weeks total), with visits every 10 days. Once patients agree to participate in the study by signing the informed consent document, a full medical and psychiatric history will be taken and a physical examination and blood draw will be performed. Screen rating scales will be performed. Screened and eligible patients will be asked to return two weeks later for a baseline visit when they will be randomized to double-blind treatment with placebo or Deplin (drug name: 6(S)-5-MTHF). The double-blind treatment will last 60 days, during which patients will be seen every 10 days. Subjects will be randomized to one of three treatment groups: a)drug/drug, b) placebo/drug, c) placebo/placebo. Patients will have a greater than 50% chance of receiving active medication (Deplin) at some point in the 8 week study

For patients randomly assigned to the drug/drug sequence, the dose of 6(S)-5-MTHF will be 7.5 mg/day during the first phase of the study, and 15 mg/d during the second phase of the study.
For patients randomly assigned to the placebo/drug sequence, the dose of 6(S)-5-MTHF will be 7.5 mg/day during the second phase of the study.
For patients randomly assigned to the placebo/placebo sequence, both tablets of study medication will be placebo during both phases of the study.

All patients will be asked to take two tablets of blinded study medication in the morning, in addition to their stable dose of ongoing SSRI treatment. Each study medication tablet will be either 7.5 mg of 6(S)-5-MTHF or matching placebo.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18-65 years old
Meet criteria for current Major Depressive Disorder
Currently taking an SSRI

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321152

Locations

United States, California
University of California San Diego School of Medicine
San Diego, California, United States, 92161
United States, Illinois
Rush University Medical Center, Psychiatric Medicine Associates, LLC
Chicago, Illinois, United States, 60612
United States, Louisiana
Lousiana State University Health Sciences Center
New Orleans, Louisiana, United States, 70115
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Burlington Medical Associates
Burlington, Massachusetts, United States, 01803
Waltham Family Practice
Waltham, Massachusetts, United States, 02453
Charles River Medical Associates
Westborough, Massachusetts, United States, 01581
United States, Ohio
Univeristy of Cincinnati, College of Medicine
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Southeast Health Consultants, LLC
Charleston, South Carolina, United States, 29407
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212

Sponsors and Collaborators

Massachusetts General Hospital

Pamlab, L.L.C.

Investigators

Principal Investigator:

George I Papakostas, M.D

Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hospital ( George Papakostas )
Study ID Numbers:	2006P000604
Study First Received:	May 1, 2006
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00321152
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major

Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009