N/A N=23 Randomized Triple-blind Treatment

A Trial of SAMe for Treatment-Resistant Bipolar Depression

Bipolar Disorder · Depression · Bipolar Depression

Bottom Line

View on ClinicalTrials.gov: NCT00762268 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Montgomery-Asberg Depression Scale (MADRS) — 29.4; 28.3; 24.7; 24.2 units on a scale — p=1.0

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SAMe (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mclean Hospital
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Montgomery-Asberg Depression Scale (MADRS)	29.4; 28.3; 24.7; 24.2; 26.3; 23.0	1.0
SECONDARY Hamilton Rating Scale for Depression	11.9; 7.3	0.05
SECONDARY Young Mania Rating Scale	2.8; 1.8	0.05

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00762268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.