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

This study is not yet open for patient recruitment.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

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

Condition Treatment or Intervention
Depression
 Drug: S-adenosyl-l-methionine (SAMe)
 Drug: Escitalopram

MedlinePlus related topics:  Depression

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: Depressive symptoms
Expected Total Enrollment:  300

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   -   80 Years,  Genders Eligible for Study:  Both

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

Location Information

Maurizio Fava, MD      617-512-4365    mfava@partners.org

Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States
Deborah Shear  617-726-0517    dshear@partners.org 
Maurizio Fava, MD,  Principal Investigator

Rhode Island
      Butler Hospital, Providence,  Rhode Island,  02906,  United States
Sandra Tavares, RN  401-455-6395    stavares@butler.org 
Lawrence Price, MD,  Principal Investigator

Study chairs or principal investigators

Maurizio Fava, MD,  Principal Investigator,  Massachusetts General Hospital   

More Information

Study ID Numbers:  AT001638-01A1
Record last reviewed:  January 2005
Last Updated:  January 10, 2005
Record first received:  January 10, 2005
ClinicalTrials.gov Identifier:  NCT00101452
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005