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

NCT00101452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2017-04-04

Study results available
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Summary

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

Conditions

Interventions

DRUG

S-adenosyl-l-methionine

1600 mg per day with possibility of increasing to 3200 mg per day at 6 weeks

DRUG

Escitalopram

10 mg per day, with possibility of increasing to 20 mg/day at 6 weeks

DRUG

Placebo

placebo capsules look like escitalopram capsules and SAMe capsules

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Maurizio Fava, MD

    lead OTHER

Principal Investigators

  • Maurizio Fava, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00101452 on ClinicalTrials.gov