A Trial of SAMe for Treatment-Resistant Bipolar Depression

NCT00762268 | Completed Results

• 1 other identifier: 2008-P-000276
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Depression; Bipolar Depression

Keywords

SAMe; alternative treatments; bipolar disorder; depression; bipolar depression; treatment-resistant depression

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Scale (MADRS)

  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.

  At each weekly visit for 4 weeks

Secondary Outcomes (2)

• Hamilton Rating Scale for Depression

  6-weeks

• Young Mania Rating Scale

  6-weeks

Study Arms (2)

SAMe

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: S-adenosyl-L-methionine

SAMe

Placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bipolar disorder
• depressed for 3-12 months
• mood unresponsive to at least 2 treatments
• currently on mood stabilizer at therapeutic doses

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (1)

• 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.

  PMID: 24699040 RESULT

Related Links

• link to hospital web site with clinical trials information

MeSH Terms

Conditions

Bipolar Disorder; Depression; Depressive Disorder, Treatment-Resistant

Interventions

S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Depressive Disorder

Intervention Hierarchy (Ancestors)

Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Beth Murphy MD
• Organization: McLean Hospital

BMurphy5@partners.org

617-855-2297

Study Officials

• Beth L Murphy, MD, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 26, 2019
• Results First Posted: August 26, 2014

Record last verified: 2019-02

Locations

US (1)