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Study of 6(S)-5-MTHF Among Selective Serotonin Reuptake Inhibitor-Resistant Outpatients With Major Depressive Disorder (TRD-2)
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Depression | Other: 6(S)-5-MTHF(Deplin) Other: Placebo | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | TRD - 2: A Double-Blind, Placebo Controlled Study of 6(S)-5-MTHF Among SSRI-Resistant Outpatients With Major Depressive Disorder (MDD) |
- 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).
- 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.
| Enrollment: | 75 |
| Study Start Date: | July 2009 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 6(S)-5-MTHF(Deplin)
Participants will receive 15 mg/day of Deplin, a medical food, for 8 weeks. The SPCD approach, is modified and conducted as follows: The phase II dataset of interest is limited to patients treated with placebo during phase I who completed phase I, who did not experience a clinical response according to the HDRS-17 during phase I and entered phase II. Drug is compared to placebo in phase II for this patient subset alone. The ITT/LOCF data comparing drug and placebo during phase I is combined with the data comparing drug and placebo according to the SPCD model for phase II (see steps 2 and 3 above), and analyzed using the statistical model as described in Fava et al, 2003 |
Other: 6(S)-5-MTHF(Deplin)
Deplin is a medical food. Patients will take 15 mg/day of deplin.
|
|
Experimental: Placebo/Deplin
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. The SPCD approach, is modified and conducted as follows: The phase II dataset of interest is limited to patients treated with placebo during phase I who completed phase I, who did not experience a clinical response according to the HDRS-17 during phase I and entered phase II. Drug is compared to placebo in phase II for this patient subset alone. The ITT/LOCF data comparing drug and placebo during phase I is combined with the data comparing drug and placebo according to the SPCD model for phase II (see steps 2 and 3 above), and analyzed using the statistical model as described in Fava et al, 2003 |
Other: 6(S)-5-MTHF(Deplin)
Deplin is a medical food. Patients will take 15 mg/day of deplin.
Other: Placebo
Inactive substance
|
|
Experimental: Placebo/Placebo
Participants will receive placebo for both phases of the study. The SPCD approach, is modified and conducted as follows: The phase II dataset of interest is limited to patients treated with placebo during phase I who completed phase I, who did not experience a clinical response according to the HDRS-17 during phase I and entered phase II. Drug is compared to placebo in phase II for this patient subset alone. The ITT/LOCF data comparing drug and placebo during phase I is combined with the data comparing drug and placebo according to the SPCD model for phase II (see steps 2 and 3 above), and analyzed using the statistical model as described in Fava et al, 2003 |
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 (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00955955
| United States, California | |
| University of California San Diego School of Medicine | |
| San Diego, California, United States, 92093 | |
| United States, Illinois | |
| Rush University Medical Center, Psychiatric Medicine Associates, LLC | |
| Chicago, Illinois, United States, 60612 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Ohio | |
| University of Cincinnati, College of Medicine | |
| Cincinnati, Ohio, United States, 45221 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | George I. Papakostas, MD | Massachusetts General Hospital |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | George I. Papakostas, Director of Treatment Resistant Depression Studies-DCRP, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00955955 History of Changes |
| Other Study ID Numbers: |
2006P000604 (2) |
| Study First Received: | July 30, 2009 |
| Results First Received: | October 31, 2012 |
| Last Updated: | March 28, 2017 |
Keywords provided by George I. Papakostas, Massachusetts General Hospital:
|
Depression Medical food |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Serotonin Uptake Inhibitors |
Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on August 18, 2017