TRD-2: A Study of 6(S)-5-MTHF Among Selective 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:	NCT00955955

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
Depression	Other: 6(S)-5-MTHF (a Medical Food) -- Deplin Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	TRD - 2: A Double-Blind, Placebo Controlled Study of 6(S)-5-MTHF Among SSRI-Resistant Outpatients With Major Depressive Disorder (MDD)

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Serotonin

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

The 28-item Hamilton Depression Scale (HAM-D-28) [ Time Frame: Screen, Baseline, Day 10, Day 20, Day 30, Day 40, Day 50, Day 60, Day 150, Day 240, Day 330, Day 420 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR), 16-item [ Time Frame: Screen, Baseline, Day 10, Day 20, Day 30, Day 40, Day 50, Day 60, Day 150, Day 240, Day 330, Day 420 ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	July 2009
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Deplin/Deplin: Experimental Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.	Other: 6(S)-5-MTHF (a Medical Food) -- Deplin If the subject is eligible, they will be asked to return two weeks later for a baseline visit, when they will be randomly assigned, to one of three treatment groups: a) drug/drug, b) placebo/drug, c) placebo/placebo (a placebo is a pill that looks like a study drug but contains no active medication). Subjects will have a greater than 50% chance of receiving active medication (Deplin) at some point in the 8 week study. Subjects will be asked to take the study medication in the morning, in addition to their ongoing SSRI treatment. At the end of the study, they will have the option of receiving free, open-label treatment with 15 mg/day of Deplin for 12 months. If subjects agree to receive open-label treatment with Deplin for 12 months, they will be assessed every three (3) months until the end of the follow-up phase. The dose of their current antidepressant treatment can be adjusted during the 12 months of follow-up, as well as the dose of Deplin (to 15 mg twice a day).
Placebo/Deplin: Experimental Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.	Other: 6(S)-5-MTHF (a Medical Food) -- Deplin If the subject is eligible, they will be asked to return two weeks later for a baseline visit, when they will be randomly assigned, to one of three treatment groups: a) drug/drug, b) placebo/drug, c) placebo/placebo (a placebo is a pill that looks like a study drug but contains no active medication). Subjects will have a greater than 50% chance of receiving active medication (Deplin) at some point in the 8 week study. Subjects will be asked to take the study medication in the morning, in addition to their ongoing SSRI treatment. At the end of the study, they will have the option of receiving free, open-label treatment with 15 mg/day of Deplin for 12 months. If subjects agree to receive open-label treatment with Deplin for 12 months, they will be assessed every three (3) months until the end of the follow-up phase. The dose of their current antidepressant treatment can be adjusted during the 12 months of follow-up, as well as the dose of Deplin (to 15 mg twice a day). Other: Placebo Inactive substance
Placebo/Placebo: Experimental Both tablets of study medication will be placebo during both phases of the study.	Other: 6(S)-5-MTHF (a Medical Food) -- Deplin If the subject is eligible, they will be asked to return two weeks later for a baseline visit, when they will be randomly assigned, to one of three treatment groups: a) drug/drug, b) placebo/drug, c) placebo/placebo (a placebo is a pill that looks like a study drug but contains no active medication). Subjects will have a greater than 50% chance of receiving active medication (Deplin) at some point in the 8 week study. Subjects will be asked to take the study medication in the morning, in addition to their ongoing SSRI treatment. At the end of the study, they will have the option of receiving free, open-label treatment with 15 mg/day of Deplin for 12 months. If subjects agree to receive open-label treatment with Deplin for 12 months, they will be assessed every three (3) months until the end of the follow-up phase. The dose of their current antidepressant treatment can be adjusted during the 12 months of follow-up, as well as the dose of Deplin (to 15 mg twice a day). Other: Placebo Inactive substance

Detailed Description:

The study consists of two phases, each lasting a total of four weeks (8 weeks total), with visits at the DCRP every 10 days. If the subject is eligible, they will be asked to return two weeks later for a baseline visit, when they will be randomly assigned, like a flip of a coin, to one of three treatment groups: a) drug/drug, b) placebo/drug, c) placebo/placebo (a placebo is a pill that looks like a study drug but contains no active medication). They will have a greater than 50% chance of receiving active medication (Deplin) at some point in the 8 week study.

Neither the subject nor the research staff will know which group the subject is in.

All subjects will be asked to take the study medication in the morning, in addition to their ongoing SSRI treatment.

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), 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: NCT00955955

Contacts

Contact: George I Papakostas, M.D.

617-726-6697

gpapakostas@partners.org

Locations

United States, California
University of California San Diego School of Medicine	Recruiting
San Diego, California, United States, 92093
Contact: Sidney Zisook, M.D. szisook@ucsd.edu
Principal Investigator: Sidney Zisook, M.D.
United States, Illinois
Rush University Medical Center, Psychiatric Medicine Associates, LLC	Recruiting
Chicago, Illinois, United States, 60612
Contact: John Zajecka, M.D. John_Zajecka@rush.edu
Principal Investigator: John Zajecka, M.D.
United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: George Papakostas, M.D. gpapakostas@partners.org
Principal Investigator: George Papakostas, M.D.
United States, Ohio
University of Cincinnati, College of Medicine	Recruiting
Cincinnati, Ohio, United States, 45221
Contact: Erik Nelson, M.D. erik.nelson@uc.edu
Principal Investigator: Erik Nelson, M.D.
United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Karl Rickels, M.D. krickels@upenn.edu
Principal Investigator: Karl Rickels, M.D.
United States, Tennessee
Vanderbilt University Medical Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Richard Shelton, M.D. richard.shelton@vanderbilt.edu
Principal Investigator: Richard Shelton, M.D.

Sponsors and Collaborators

Massachusetts General Hospital

Pamlab, L.L.C.

Investigators

Principal Investigator:

George I. Papakostas, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital ( George Papakostas )
Study ID Numbers:	2006P000604 (2)
Study First Received:	July 30, 2009
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00955955 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Depression
Medical food

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major

Depressive Disorder
Serotonin Uptake Inhibitors
Serotonin
Antidepressive Agents
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Depressive Disorder, Major
Depressive Disorder

Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on September 11, 2009