Major Depressive Disorder Clinical Trial
Official title:
A Double-Blind, Placebo Controlled Study of 6(S)-5-MTHF Among SSRI-Resistant Outpatients With Major Depressive Disorder (MDD)
Verified date | June 2010 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 150 |
Est. completion date | June 2010 |
Est. primary completion date | August 2008 |
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), or any psychotic disorder (current or past). - Have failed more than 2 adequate antidepressant trials during the current Major Depressive Episode. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Burlington Medical Associates | Burlington | Massachusetts |
United States | Southeast Health Consultants, LLC | Charleston | South Carolina |
United States | Rush University Medical Center, Psychiatric Medicine Associates, LLC | Chicago | Illinois |
United States | Univeristy of Cincinnati, College of Medicine | Cincinnati | Ohio |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Lousiana State University Health Sciences Center | New Orleans | Louisiana |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of California San Diego School of Medicine | San Diego | California |
United States | Waltham Family Practice | Waltham | Massachusetts |
United States | Charles River Medical Associates | Westborough | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Pamlab, L.L.C. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HAM-D | every visit | No | |
Secondary | QIDS-SR | every visit | No |
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