At a glance
ClinicalIndex Comparison RecordN/ACompleted· 199 enrolled
Drug / intervention
S-adenosyl-l-methionine +2 moredrug
Likely dose
SAMe 1600 mg per day (escalatable to 3200 mg at 6 weeks) or escitalopram 10 mg per day (escalatable to 20 mg at 6 weeks)AI-extracted
Key inclusion· 3
- ✓Confirmed diagnosis of major depressive disorder
- ✓IDS-C score of 25 or higher at baseline
- ✓CGI improvement score greater than 2
Key exclusion· 16
- ✕Active suicidal or homicidal ideation
- ✕Unstable cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
- ✕Psychotic disorder, schizophrenia, delusional disorder, bipolar disorder, or severe personality disorder (borderline or antisocial)
- ✕Substance or alcohol abuse within 6 months prior to entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Placebo-Controlled Study of the Alternative Therapy S-Adenosyl-L-Methionine (SAMe) vs Escitalopram in Major Depressive Disorder (MDD)
In Brief
A clinical study evaluating S-adenosyl-l-methionine, Escitalopram, and 1 other intervention for Depression. Completed, enrolled 199 participants across 2 sites.
Detailed Summary
The purpose of this study is to determine the safety and effectiveness of s-adenosyl-l-methionine (SAMe) in treating major depression.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
Timeline
N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2005
Enrollment StartApr 2005
Primary CompletionJun 2010
TodayJul 2026
First PostedJan 11, 2005
Enrollment StartApr 1, 2005
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 21.5 years ago
Interventions
S-adenosyl-l-methioninedrug
1600 mg per day with possibility of increasing to 3200 mg per day at 6 weeks
Escitalopramdrug
10 mg per day, with possibility of increasing to 20 mg/day at 6 weeks
Placebodrug
placebo capsules look like escitalopram capsules and SAMe capsules