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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:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00101452
First received: January 10, 2005
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: Yes ]
    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 ingrediants
 Drug: Placebo
placebo capsules look like escitalopram capsules and SAMe capsules
Other Name: Placebo

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 be switched to treatment with both 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Maurizio Fava, MD Massachusetts General Hospital
  More Information

No publications provided

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: R01 AT001638-01A1, R01AT001638-01A1
Study First Received: January 10, 2005
Results First Received: June 13, 2012
Last Updated: February 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Depression
Antidepressive Agents
Complementary Therapies

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

ClinicalTrials.gov processed this record on May 19, 2013