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

Completed · Not applicable · Has a placebo group

Conditions studied: Depression

In brief

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

Key facts

Study ID

NCT00101452

Run by

Maurizio Fava, MD

People needed

199

Starts

2005-04-01

Expected to finish

2010-06-01

Last updated by the study team

2017-04-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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