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

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Other: 6(S)-5-MTHF (a Medical Food)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00321152

2006P000604

Details and patient eligibility

About

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).

Full 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 (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)Deplin/Deplin, b) placebo/Deplin, 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 Deplin/Deplin 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/Deplin 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Deplin/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.

Treatment:

Other: 6(S)-5-MTHF (a Medical Food)

2

Experimental group

Description:

placebo/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.

Treatment:

Other: 6(S)-5-MTHF (a Medical Food)

3

Placebo Comparator group

Description:

placebo/placebo = both tablets of study medication will be placebo during both phases of the study.

Treatment:

Other: 6(S)-5-MTHF (a Medical Food)