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Completed

NCT Number: NCT00955955

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

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).

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California San Diego School of Medicine, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6(S)-5-MTHF(Deplin)

Other

Deplin is a medical food. Patients will take 15 mg/day of deplin.

Placebo

Other

Inactive substance

Primary outcomes

  1. The 17-item Hamilton Depression Scale (HAM-D-17)

    Time frame: Baseline and Day 60

    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).

Secondary outcomes

  1. The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)

    Time frame: Baseline and Day 60

    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.

Sponsors and collaborators

Lead sponsor

George I. Papakostas

Other

Collaborators

  • Pamlab, L.L.C.

Registry information

Official study title

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

Acronym: TRD-2

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 10, 2009
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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