Status:
COMPLETED
A Trial of SAMe for Treatment-Resistant Bipolar Depression
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Bipolar Disorder
Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
S-adenosyl-L-methionine (SAMe) is a dietary supplement with antidepressant properties. SAMe's mechanism of action remains unclear, but it appears to be distinct from that of conventional antidepressan...
Detailed Description
Depression in bipolar disorder is a significant source of disease-related debility; with bipolar individuals typically spending three fold as much time depressed as manic or hypomanic. Clinicians trea...
Eligibility Criteria
Inclusion
- bipolar disorder
- depressed for 3-12 months
- mood unresponsive to at least 2 treatments
- currently on mood stabilizer at therapeutic doses
Exclusion
- history of mania while on adequate mood stabilizer
- rapid cycling bipolar disorder
- previous use of SAMe during current episode
- unstable medical illness including parkinson's disease
- methotrexate use
- pregnancy
- substance abuse/dependence
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00762268
Start Date
September 1 2008
End Date
September 1 2011
Last Update
February 26 2019
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478