A Trial of SAMe for Treatment-Resistant Bipolar Depression
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bipolar Disorder Depression Bipolar Depression |
Drug: SAMe Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- MADRS [ Time Frame: At each weekly visit for 4 weeks ] [ Designated as safety issue: No ]Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and lower intensity.
- HAM-D [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]
- YMRS [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]
| Enrollment: | 17 |
| Study Start Date: | September 2008 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SAMe
SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day "rest-period", before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period.
|
Drug: SAMe
SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day "rest-period", before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period.
Other Name: S-adenosyl-L-methionine
|
|
Placebo Comparator: placebo
Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day "rest-period", before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period.
|
Drug: Placebo |
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00762268
| United States, Massachusetts | |
| McLean Hospital | |
| Belmont, Massachusetts, United States, 02478 | |
| Principal Investigator: | Beth L Murphy, MD, PhD | Mclean Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Beth L. Murphy MD, PhD, Principal Investigator, Mclean Hospital |
| ClinicalTrials.gov Identifier: | NCT00762268 History of Changes |
| Other Study ID Numbers: | 2008-P-000276 |
| Study First Received: | September 26, 2008 |
| Results First Received: | June 17, 2014 |
| Last Updated: | August 25, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mclean Hospital:
|
SAMe alternative treatments bipolar disorder |
depression bipolar depression treatment-resistant depression |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic |
Behavioral Symptoms Mental Disorders Mood Disorders |
ClinicalTrials.gov processed this record on February 27, 2015