drugset / Trial / NCT00762268

A Trial of SAMe for Treatment-Resistant Bipolar Depression

NCT00762268 ↗

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2008-09
Primary completion
2011-09
Completion
2011-09

Outcome

Missed primary endpoint

registry analysis (superiority or other test); SAMe vs Placebo; p = 1.0; Regression, Linear NCT00762268 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ademetionine Unknown 1600 mg Oral

Indications