A Trial of SAMe for Treatment-Resistant Bipolar Depression

Completed · Not applicable · Has a placebo group

Conditions studied: Bipolar Disorder, Depression, Bipolar Depression

In brief

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.

Key facts

Study ID

NCT00762268

Run by

Mclean Hospital

People needed

23

Starts

2008-09-01

Expected to finish

2011-09-01

Last updated by the study team

2019-02-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• bipolar disorder
• depressed for 3-12 months
• mood unresponsive to at least 2 treatments
• currently on mood stabilizer at therapeutic doses

You may not qualify if…

• 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

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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