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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00101452
First Posted: January 11, 2005
Last Update Posted: April 4, 2017
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:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital
  Purpose
The purpose of this study is to determine the safety and effectiveness of s-adenosyl-l-methionine (SAMe) in treating major depression.

Condition Intervention
Depression Drug: S-adenosyl-l-methionine Drug: Escitalopram Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of the Alternative Therapy S-Adenosyl-L-Methionine (SAMe) vs Escitalopram in Major Depressive Disorder (MDD)

Resource links provided by NLM:


Further study details as provided by Maurizio Fava, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 199
Study Start Date: April 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Lexapro
Placebo Comparator: 3. placebo
Sugar pill- contains no active ingredients
Drug: Placebo
placebo capsules look like escitalopram capsules and SAMe capsules

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT00101452


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Maurizio Fava, MD
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Maurizio Fava, MD Massachusetts General Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maurizio Fava, MD, Director- Depression Clinical and Research Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00101452     History of Changes
Other Study ID Numbers: R01AT001638-01A1 ( U.S. NIH Grant/Contract )
First Submitted: January 10, 2005
First Posted: January 11, 2005
Results First Submitted: June 13, 2012
Results First Posted: December 31, 2012
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Maurizio Fava, MD, Massachusetts General Hospital:
Depression
Antidepressive Agents
Complementary Therapies

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents