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SAM-e for the Treatment of Depression in Patients With Parkinson's Disease

NCT00070941 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2016-07-13

Study results available
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Summary

This study will test a chemical called s-adenosyl-methionine (SAM-e) for the treatment of depression in patients with Parkinson's disease (PD).

Conditions

Interventions

DRUG

SAM-e

oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo escitalopram.

DRUG

oral escitalopram

20mg or 30mg daily in two divided doses, along with placebo SAM-e.

DRUG

placebo

oral placebo escitalopram and oral placebo SAM-e daily in two divided doses.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Office of Dietary Supplements (ODS)

    collaborator NIH

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Alessandro Di Rocco, MD · NYU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2010-06-30
Completion
2010-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00070941 on ClinicalTrials.gov