Clinical trial NCT00762268: A Trial of SAMe for Treatment-Resistant Bipolar Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Depression
Bipolar Depression
Keywords: SAMe
alternative treatments
bipolar disorder
depression
bipolar depression
treatment-resistant depression
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2008-09-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Montgomery-Asberg Depression Scale (MADRS)
timeFrame: At each weekly visit for 4 weeks
Secondary outcomes:
measure: Hamilton Rating Scale for Depression
timeFrame: 6-weeks
measure: Young Mania Rating Scale
timeFrame: 6-weeks
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Beth L Murphy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murphy BL, Babb SM, Ravichandran C, Cohen BM. Oral SAMe in persistent treatment-refractory bipolar depression: a double-blind, randomized clinical trial. J Clin Psychopharmacol. 2014 Jun;34(3):413-6. doi: 10.1097/JCP.0000000000000064. No abstract available.