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

June 2, 2016 updated by: NYU Langone Health

SAM-e Treatment of Depression in Parkinson's Disease.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PD is commonly associated with depression, but conventional antidepressants have limited efficacy in patients with PD and may exacerbate motor symptoms. SAM-e is available in the United States as a food supplement and is promoted as a mood enhancer. SAM-e improves dopamine transmission, may have a beneficial effect on dopamine receptors, and may be a good alternative to the currently-used antidepressants in patients with PD. This study will investigate whether SAM-e is safe and effective in the treatment of depression associated with PD. The efficacy of SAM-e will be compared to placebo and to escitalopram, a selective serotonin reuptake inhibitor commonly used for the treatment of depression in PD.

Participants in this study will be randomly assigned to receive SAM-e, escitalopram, or placebo for 12 weeks. Some participants may choose to extend treatment for an additional 12 weeks (for a total of 24 weeks on study medication). Participants will have study visits at entry and Weeks 2, 4, 8, and 12. Study visits will include neurological evaluation, psychiatric evaluation, blood tests, and quality of life questionnaires. A telephone interview will be conducted at Week 10.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • New York University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Idiopathic Parkinson's disease as indicated by the presence of at least two of the following signs: resting tremor, rigidity, bradykinesia, or postural reflex impairment
  • Stable anti-parkinson medication regimen, with no change in medications in the 4 weeks prior to study entry
  • No antidepressant or antipsychotic medications within 30 days prior to study entry
  • Agree not to start other pharmacotherapy, psychotherapy, or behavior therapy while participating in the trial
  • Acceptable methods of contraception
  • Ability to read and/or follow written and oral instructions presented in English
  • Sufficient cognitive ability (baseline Mini-Mental Status > 24) to provide informed consent

Exclusion Criteria

  • History of cardiac, hepatic, renal, hematologic, respiratory, endocrine, vascular, metabolic, or other systems abnormalities that are clinically relevant in the opinion of study officials
  • Certain abnormal laboratory values
  • Pregnant or breastfeeding
  • Use of an investigational drug within 3 months of study entry
  • Use of St. John's Wort or any other "natural" product known to have mood enhancing properties in the 30 days prior to study entry
  • Selegiline or other monoamine oxidase inhibitor within the 6 weeks prior to study entry
  • Regular usage of anti-anxiety medications or habitual use of sleep medications, although occasional use of certain hypnotics (temazepam, melatonin, or zolpidem) is allowed
  • Psychotherapy initiated in the 6 months prior to study entry
  • History of bipolar disorder, hypomania, mania, schizophrenia, or other psychotic disorder
  • Serious suicidal attempt in the 12 months prior to study entry or serious suicidal tendencies/potential
  • Use of dopamine receptor antagonist (metoclopramide, haloperidol)
  • Secondary Parkinsonian symptoms due to drugs (including dopamine receptor antagonists), metabolic disorders, cerebrovascular disease, encephalitis, or other degenerative diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SAM-e
40 subjects receiving oral SAM-e, 1200mg or 1800mg daily in two divided doses, and placebo escitalopram.
Drug: SAM-e
oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo escitalopram.
Other Names:
  • 1 Experimental
ACTIVE_COMPARATOR: Escitalopram
40 subjects receiving oral escitalopram 20mg or 40 mg daily, in two divided doses, and placebo SAM-e.
Drug: oral escitalopram
20mg or 30mg daily in two divided doses, along with placebo SAM-e.
PLACEBO_COMPARATOR: Placebo Comparator
20 subjects receiving oral placebo escitalopram and placebo SAM-3 daily in two divided doses.
Drug: placebo
oral placebo escitalopram and oral placebo SAM-e daily in two divided doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hamilton Depression Scale
Time Frame: 12 weeks
very severe, >23/29; severe, 19-22/29; moderate, 14-18/29; mild, 8-13/29; and no depression, 0-7/29 (Hamilton M., J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62.)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)

Investigators

  • Principal Investigator: Alessandro Di Rocco, MD, NYU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

October 9, 2003

First Submitted That Met QC Criteria

October 10, 2003

First Posted (ESTIMATE)

October 13, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

July 13, 2016

Last Update Submitted That Met QC Criteria

June 2, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AT000941-01A1 (NIH)
  • 075255364 (OTHER_GRANT: NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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