A Trial of SAMe for Treatment-Resistant Bipolar Depression

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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 antidepressants. The purpose of this study is to examine the effect of these properties on the mood of bipolar subjects with persistent major depression that has been unresponsive to standard pharmacotherapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mclean Hospital
• Collaborator: Stanley Medical Research Institute

Criteria

Inclusion Criteria:

• bipolar disorder

• depressed for 3-12 months

• mood unresponsive to at least 2 treatments

• currently on mood stabilizer at therapeutic doses

Exclusion Criteria:

• 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