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A Trial of SAMe for Treatment-Resistant Bipolar Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00762268
First Posted: September 30, 2008
Last Update Posted: August 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital
  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
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

Resource links provided by NLM:


Further study details as provided by Beth L. Murphy MD, PhD, Mclean Hospital:

Primary Outcome Measures:
  • 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:
  • HAM-D [ Time Frame: 6-weeks ]
  • YMRS [ Time Frame: 6-weeks ]

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

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
  Contacts and Locations
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
  More Information

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 Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: June 17, 2014
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