CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
S-adenosyl methione (SAMe) +1 moredrug
Likely dose
S-adenosyl methionine (SAMe) oral tosylate, up to 1600 mg per day for 6 weeksAI-extracted
Key inclusion· 2
  • ✓Diagnosed with major depressive disorder
  • ✓Currently taking an SSRI for at least 6 weeks with partial or no response to treatment
Key exclusion· 3
  • ✕History of psychosis
  • ✕Known allergy to SAMe
  • ✕Alcohol or drug abuse within the past 3 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00093847
NCT00093847Phase 2Completed
CompareCT.gov

S-adenosyl Methionine (SAMe) Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) for Treatment-Resistant Depression (TRD)

Massachusetts General Hospital·interventional·Posted Oct 8, 2004·Updated Oct 13, 2014

In Brief

A Phase 2 clinical trial evaluating S-adenosyl methione (SAMe) and Placebo for Depression. Completed, enrolled 73 participants across 1 site.

Detailed Summary

This study will determine the effectiveness of adding S-adenosyl methionine to antidepressant drug treatment in reducing depressive symptoms in depressed people who have not responded to antidepressants alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 8, 2004
Enrollment StartMay 1, 2004
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 21.7 years ago

Interventions

S-adenosyl methione (SAMe)drug

Oral SAMe tosylate, up to 1600 mg per day for 6 weeks

Placebodrug

Placebo to be taken daily for 6 weeks