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Completed

NCT Number: NCT00762268

A Trial of SAMe for Treatment-Resistant Bipolar Depression

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.

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Key information

Conditions

Bipolar Disorder Behavior Behavioral Symptoms Bipolar Depression Bipolar and Related Disorders Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAMe

Drug

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 names: S-adenosyl-L-methionine

Placebo

Drug

Primary outcomes

  1. Montgomery-Asberg Depression Scale (MADRS)

    Time frame: At each weekly visit for 4 weeks

    Assessment of current depression symptoms using Montgomery-Asberg Depression Scale (MADRS). All 10 questions on the scale have a 0 (absent)-6(most severe) range for describing symptoms, with the total ranging from 0-60. 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 outcomes

  1. Hamilton Rating Scale for Depression

    Time frame: 6-weeks

    Rating scale of depression symptoms (range 0-50). 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.

  2. Young Mania Rating Scale

    Time frame: 6-weeks

    Rating scale for manic symptoms (range 0-60). 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.

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2008
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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