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

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

Detailed Description
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Drug: S-adenosyl-l-methionine
* Drug: Escitalopram
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-adenosyl-l-methionine (SAMe)<br>A natural substance | Drug: S-adenosyl-l-methionine<br>* 1600 mg per day with possibility of increasing to 3200 mg per day at 6 weeks<br>* Other names: SAMe;|
| Active Comparator: 2. Escitalopram<br>A selective serotonin reuptake inhibitor (SSRI) | Drug: Escitalopram<br>* 10 mg per day, with possibility of increasing to 20 mg/day at 6 weeks<br>* Other names: Lexapro;|
| Placebo Comparator: 3. placebo<br>Sugar pill- contains no active ingredients | Drug: Placebo<br>* placebo capsules look like escitalopram capsules and SAMe capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression (HAM-D) | 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. | baseline and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Antidepressive Agents, Complementary Therapies