N/A
Completed N=23
A Trial of SAMe for Treatment-Resistant Bipolar Depression
Source: ClinicalTrials.gov NCT00762268 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Montgomery-Asberg Depression Scale (MADRS) — 29.4; 28.3; 24.7; 24.2 units on a scale — p=1.0
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.
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 |
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
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. Informational only — not medical advice.