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

Primary Purpose

Parkinson's Disease, Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SAM-e
oral escitalopram
placebo
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinsons Disease, Depression, SAM-e

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

SAM-e

Escitalopram

Placebo Comparator

Arm Description

40 subjects receiving oral SAM-e, 1200mg or 1800mg daily in two divided doses, and placebo escitalopram.

40 subjects receiving oral escitalopram 20mg or 40 mg daily, in two divided doses, and placebo SAM-e.

20 subjects receiving oral placebo escitalopram and placebo SAM-3 daily in two divided doses.

Outcomes

Primary Outcome Measures

Change in Hamilton Depression Scale
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.)

Secondary Outcome Measures

Full Information

First Posted
October 9, 2003
Last Updated
June 2, 2016
Sponsor
NYU Langone Health
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
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1. Study Identification

Unique Protocol Identification Number
NCT00070941
Brief Title
SAM-e for the Treatment of Depression in Patients With Parkinson's Disease
Official Title
SAM-e Treatment of Depression in Parkinson's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Depression
Keywords
Parkinsons Disease, Depression, SAM-e

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAM-e
Arm Type
Experimental
Arm Description
40 subjects receiving oral SAM-e, 1200mg or 1800mg daily in two divided doses, and placebo escitalopram.
Arm Title
Escitalopram
Arm Type
Active Comparator
Arm Description
40 subjects receiving oral escitalopram 20mg or 40 mg daily, in two divided doses, and placebo SAM-e.
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
20 subjects receiving oral placebo escitalopram and placebo SAM-3 daily in two divided doses.
Intervention Type
Drug
Intervention Name(s)
SAM-e
Other Intervention Name(s)
1 Experimental
Intervention Description
oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo escitalopram.
Intervention Type
Drug
Intervention Name(s)
oral escitalopram
Intervention Description
20mg or 30mg daily in two divided doses, along with placebo SAM-e.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral placebo escitalopram and oral placebo SAM-e daily in two divided doses.
Primary Outcome Measure Information:
Title
Change in Hamilton Depression Scale
Description
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.)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Di Rocco, MD
Organizational Affiliation
NYU
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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