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A Trial of SAMe for Treatment-Resistant Bipolar Depression

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ClinicalTrials.gov Identifier: NCT00762268
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : August 26, 2014
Last Update Posted : August 26, 2014
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital

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.

Condition or disease Intervention/treatment
Bipolar Disorder Depression Bipolar Depression Drug: SAMe 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : September 2008
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Methionine
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. MADRS [ Time Frame: At each weekly visit for 4 weeks ]
    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.


Secondary Outcome Measures :
  1. HAM-D [ Time Frame: 6-weeks ]
  2. YMRS [ Time Frame: 6-weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762268


Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Stanley Medical Research Institute
Investigators
Principal Investigator: Beth L Murphy, MD, PhD Mclean Hospital

Additional Information:
Publications:
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
First Posted: September 30, 2008    Key Record Dates
Results First Posted: August 26, 2014
Last Update Posted: August 26, 2014
Last Verified: August 2014

Keywords provided by Beth L. Murphy MD, PhD, Mclean Hospital:
SAMe
alternative treatments
bipolar disorder
depression
bipolar depression
treatment-resistant depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders