Status:
COMPLETED
Safety and Effectiveness of S-adenosyl-l-methionine (SAMe) for the Treatment of Major Depression
Lead Sponsor:
Maurizio Fava, MD
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Depression
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the safety and effectiveness of s-adenosyl-l-methionine (SAMe) in treating major depression.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT00101452
Start Date
April 1 2005
End Date
June 1 2010
Last Update
April 4 2017
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Butler Hospital
Providence, Rhode Island, United States, 02906