Safety and Effectiveness of S-adenosyl-l-methionine (SAMe) for the Treatment of Major Depression
The purpose of this study is to determine the safety and effectiveness of s-adenosyl-l-methionine (SAMe) in treating major depression.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Placebo-Controlled Study of the Alternative Therapy S-Adenosyl-L-Methionine (SAMe) vs Escitalopram in Major Depressive Disorder (MDD)|
- Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||April 2005|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Experimental: S-adenosyl-l-methionine (SAMe)
A natural substance
1600 mg per day with possibility of increasing to 3200 mg per day at 6 weeks
Other Name: SAMe
Active Comparator: 2. Escitalopram
A selective serotonin reuptake inhibitor (SSRI)
10 mg per day, with possibility of increasing to 20 mg/day at 6 weeks
Other Name: Lexapro
Placebo Comparator: 3. placebo
SUgar pill- contains no active ingrediants
placebo capsules look like escitalopram capsules and SAMe capsules
Other Name: Placebo
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 be switched to treatment with both 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101452
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Principal Investigator:||Maurizio Fava, MD||Massachusetts General Hospital|