Safety and Effectiveness of S-adenosyl-l-methionine (SAMe) for the Treatment of Major Depression
Depression
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Antidepressive Agents, Complementary Therapies
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
- Butler Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
S-adenosyl-l-methionine (SAMe)
2. Escitalopram
3. placebo
A natural substance
A selective serotonin reuptake inhibitor (SSRI)
Sugar pill- contains no active ingredients