Study of 6(S)-5-MTHF Among Selective Serotonin Reuptake Inhibitor-Resistant Outpatients With Major Depressive Disorder

Depression Clinical Trial

— TRD-2  

Official title:

TRD - 2: A Double-Blind, Placebo Controlled Study of 6(S)-5-MTHF Among SSRI-Resistant Outpatients With Major Depressive Disorder (MDD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955955
• Other study ID #: 2006P000604 (2)
• Status: Completed
• Phase: Phase 4
• First received: July 30, 2009
• Last updated: May 7, 2013
• Start date: July 2009
• Est. completion date: April 2011

Study information

• Verified date: May 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Other:
• 6(S)-5-MTHF(Deplin)
Deplin is a medical food. Patients will take 15 mg/day of deplin.
• Placebo
Inactive substance

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Rush University Medical Center, Psychiatric Medicine Associates, LLC	Chicago	Illinois
United States	University of Cincinnati, College of Medicine	Cincinnati	Ohio
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of California San Diego School of Medicine	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
George I. Papakostas	Pamlab, L.L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 17-item Hamilton Depression Scale (HAM-D-17)	The HAM-D-17 is a multiple choice questionnaire that clinicians may use to rate the severity of a patient's major depression. Items are scored on a scale of zero to four and higher scores indicate greater impairment. This scale is scored by summing the scores on each item and scores can range from 0-68.; When assessing changes in HAMD score, negative changes indicate improvement (i.e. the score has decreased) and positive scores indicate a worsening of symptoms (i.e. scores have increased).	Baseline and Day 60	No
Secondary	The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)	This measure is a 16 item self report questionnaire assessing symptoms of depression. For each item, scores range from 0 to 3 with higher scores indicating greater impairment. To score this measure: Enter the highest score from questions 1-4 (sleep items): ______; Enter score on item 5 ____; Enter the highest score from questions 6-9 (appetite/weight): ______; Enter score on item 10 ____; Enter score on item 11 ____; Enter score on item 12 ____; Enter score on item 13 ____; Enter score on item 14 ____; Enter the highest score from questions 15-16 (psychomotor items): ______; Total score range 0-27: ______; When assessing changes in this measure over time, negative means indicate an improvement (i.e. the scores decreased over time) and positive means indicate worsening in functioning.	Baseline and Day 60	No