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Completed

NCT Number: NCT00101452

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

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S-adenosyl-L-methionine

Drug

1600 mg per day with possibility of increasing to 3200 mg per day at 6 weeks

Other names: SAMe

Escitalopram

Drug

10 mg per day, with possibility of increasing to 20 mg/day at 6 weeks

Other names: Lexapro

Placebo

Drug

placebo capsules look like escitalopram capsules and SAMe capsules

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Maurizio Fava, MD

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Jan 11, 2005
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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