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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maurizio Fava, MD
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Citalopram; Dexetimide

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