A Trial of SAMe for Treatment-Resistant Bipolar Depression
| Status: | Completed |
|---|---|
| Conditions: | Depression, Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/28/2019 |
| Start Date: | September 2008 |
| End Date: | September 2011 |
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.
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.
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.
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
We found this trial at
1
site
McLean Hospital McLean Hospital is a comprehensive psychiatric hospital committed to providing easy access to...
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