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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00070941
Recruitment Status : Completed
First Posted : October 13, 2003
Results First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Parkinson's Disease Depression Drug: SAM-e Drug: oral escitalopram Drug: placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: SAM-e Treatment of Depression in Parkinson's Disease.
Study Start Date : July 2003
Actual Primary Completion Date : June 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.)


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070941


Locations
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United States, New York
New York University
New York, New York, United States, 10003
Sponsors and Collaborators
NYU Langone Health
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Investigators
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Principal Investigator: Alessandro Di Rocco, MD NYU
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00070941    
Other Study ID Numbers: R01AT000941-01A1 ( U.S. NIH Grant/Contract )
R01AT000941-01A1 ( U.S. NIH Grant/Contract )
075255364 ( Other Grant/Funding Number: NIH )
First Posted: October 13, 2003    Key Record Dates
Results First Posted: July 13, 2016
Last Update Posted: July 13, 2016
Last Verified: June 2016
Keywords provided by NYU Langone Health:
Parkinsons Disease
Depression
SAM-e
Additional relevant MeSH terms:
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Parkinson Disease
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
 Neurodegenerative Diseases
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs