Safety and Effectiveness of S-adenosyl-l-methionine (SAMe) for the Treatment of Major Depression

March 6, 2017 updated by: Maurizio Fava, MD

A Double-Blind, Placebo-Controlled Study of the Alternative Therapy S-Adenosyl-L-Methionine (SAMe) vs Escitalopram in Major Depressive Disorder (MDD)

The purpose of this study is to determine the safety and effectiveness of s-adenosyl-l-methionine (SAMe) in treating major depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

SAMe is a substance that is naturally produced by the body and is also sold as an over-the-counter drug. Although SAMe has not yet been approved for treating depression, evidence suggests that it has antidepressant properties. This study will determine whether SAMe is safe and effective in treating major depression.

This study will last 24 weeks. Participants will be randomly assigned to receive either the antidepressant escitalopram, SAMe, or placebo for 12 weeks. Participants who respond to treatment at the end of 12 weeks will stay on their regimen for an additional 12 weeks. Participants who do not respond to treatment will enter an open treatment phase where they will receive SAMe and escitalopram for 12 more weeks. Depression scales and self-report questionnaires will be used to assess participants. All participants will receive 3 months of follow-up care, including free medication and clinic visits as necessary.

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of major depression
  • Score of 25 or higher on the Inventory of Depressive Symptomatology (IDS-C) scale
  • Score of higher than 2 on the Clinical Global Impression Improvement (CGI) scale
  • Willing to use acceptable methods of contraception

Exclusion Criteria:

  • Suicidal or homicidal
  • Unstable illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
  • Any of the following mental conditions: organic mental disorders; schizophrenia; delusional disorder; psychotic disorders; bipolar disorder; recent bereavement; severe borderline or antisocial personality disorder; panic disorder; or obsessive compulsive disorder
  • Substance abuse, including alcohol abuse, within 6 months prior to study entry
  • Uncontrolled seizure disorder, or a seizure disorder controlled with psychotropic anticonvulsants
  • Psychotic features
  • Current use of other psychotropic drugs
  • Hypothyroidism
  • Have taken 6 weeks or more of either escitalopram or SAMe during the current depressive episode
  • Previous intolerance of SAMe or escitalopram
  • Investigational psychotropic drugs within 1 year prior to study entry
  • Have received two or more antidepressant therapies of adequate doses and duration and failed to respond
  • Have received depression-focused psychotherapy
  • Bleeding tissue disorder, low platelet counts, a history of GI bleeding, or use of medications that alter bleeding risk
  • Long-term aspirin use
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-adenosyl-l-methionine (SAMe)
A natural substance
Drug: S-adenosyl-l-methionine
1600 mg per day with possibility of increasing to 3200 mg per day at 6 weeks
Other Names:
  • SAMe
Active Comparator: 2. Escitalopram
A selective serotonin reuptake inhibitor (SSRI)
Drug: Escitalopram
10 mg per day, with possibility of increasing to 20 mg/day at 6 weeks
Other Names:
  • Lexapro
Placebo Comparator: 3. placebo
Sugar pill- contains no active ingredients
Drug: Placebo
placebo capsules look like escitalopram capsules and SAMe capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Rating Scale for Depression (HAM-D)
Time Frame: baseline and 24 weeks
The change in total HAM-D score between baseline and endpoint was the primary outcomes measure. This measure is a clinician rated inventory of depressive symptoms. All items are scored on a scale of zero to four and the sum of the scores provides the total score for the measure. Scores can range from 0- 68. On this scale, higher scores indicate poorer outcomes.
baseline and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maurizio Fava, MD

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

January 10, 2005

First Submitted That Met QC Criteria

January 10, 2005

First Posted (Estimate)

January 11, 2005

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AT001638-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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