Depression Clinical Trial
Official title:
Intermittent-Dose Oral SAMe (S-adenosyl-L-methionine) in Persistent and Treatment-Refractory Bipolar Depression: A Double-Blind Pilot Trial With an Optional Open-label Follow-up
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.
Depression in bipolar disorder is a significant source of disease-related debility; with
bipolar individuals typically spending three fold as much time depressed as manic or
hypomanic. Clinicians treating bipolar disorder often struggle to provide relief from
depressive symptoms that are more often treatment resistant than in unipolar depression. To
complicate matters further, the risk/benefit ratio of currently available antidepressants is
a source of debate within the field of psychiatry.
S-adenosyl-L-methionine (SAMe) is a dietary supplement with well-established 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.
An unusual aspect of the current study design is the schedule of SAMe dosing. SAMe tablets
will be administered intermittently and in steadily increasing dosages. The purpose of this
gradual and intermittent dosage titration is to lessen the risk of antidepressant-induced
mania by seeking the minimum effective oral dose of SAMe.
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