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| Name | Class |
|---|---|
| Pamlab, L.L.C. | INDUSTRY |
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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).
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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. |
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| 2 | Experimental | 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. |
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| 3 | Placebo Comparator | placebo/placebo = both tablets of study medication will be placebo during both phases of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6(S)-5-MTHF (a Medical Food) | Other | 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 (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. |
| Measure | Description | Time Frame |
|---|---|---|
| HAM-D | every visit |
| Measure | Description | Time Frame |
|---|---|---|
| QIDS-SR | every visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George I Papakostas, M.D | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego School of Medicine | San Diego | California | 92161 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27035404 | Derived | Zajecka JM, Fava M, Shelton RC, Barrentine LW, Young P, Papakostas GI. Long-term efficacy, safety, and tolerability of L-methylfolate calcium 15 mg as adjunctive therapy with selective serotonin reuptake inhibitors: a 12-month, open-label study following a placebo-controlled acute study. J Clin Psychiatry. 2016 May;77(5):654-60. doi: 10.4088/JCP.15m10181. | |
| 23212058 |
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| Rush University Medical Center, Psychiatric Medicine Associates, LLC |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Lousiana State University Health Sciences Center | New Orleans | Louisiana | 70115 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Burlington Medical Associates | Burlington | Massachusetts | 01803 | United States |
| Waltham Family Practice | Waltham | Massachusetts | 02453 | United States |
| Charles River Medical Associates | Westborough | Massachusetts | 01581 | United States |
| Univeristy of Cincinnati, College of Medicine | Cincinnati | Ohio | 45267 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Southeast Health Consultants, LLC | Charleston | South Carolina | 29407 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Papakostas GI, Shelton RC, Zajecka JM, Etemad B, Rickels K, Clain A, Baer L, Dalton ED, Sacco GR, Schoenfeld D, Pencina M, Meisner A, Bottiglieri T, Nelson E, Mischoulon D, Alpert JE, Barbee JG, Zisook S, Fava M. L-methylfolate as adjunctive therapy for SSRI-resistant major depression: results of two randomized, double-blind, parallel-sequential trials. Am J Psychiatry. 2012 Dec;169(12):1267-74. doi: 10.1176/appi.ajp.2012.11071114. |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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