Phase 2 N=73 Randomized Double-blind Treatment

Optimizing the Effectiveness of Selective Serotonin Reuptake Inhibitors (SSRIs) in Treatment-Resistant Depression

Depression

Bottom Line

View on ClinicalTrials.gov: NCT00093847 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcome: Primary: Hamilton Depression Rating Scale Remission Rates — 46.1; 17.6 Percentage of Remitters HDRS17

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: S-adenosyl methione (SAMe) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Hamilton Depression Rating Scale Remission Rates	46.1; 17.6	—
SECONDARY HDRS17 Responders	35.8; 11.7	—

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.

Eligibility Criteria

Inclusion Criteria

Major depressive disorder
Use of an SSRI for at least 6 weeks prior to study entry with partial or no response

Exclusion Criteria

History of psychosis
Allergy to SAMe
Alcohol or drug abuse in the past 3 months prior to study entry

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00093847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.