- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00070941
SAM-e for the Treatment of Depression in Patients With Parkinson's Disease
SAM-e Treatment of Depression in Parkinson's Disease.
Study Overview
Status
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10003
- New York University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo escitalopram.
Other Names:
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ACTIVE_COMPARATOR: Escitalopram
40 subjects receiving oral escitalopram 20mg or 40 mg daily, in two divided doses, and placebo SAM-e.
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20mg or 30mg daily in two divided doses, along with placebo SAM-e.
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PLACEBO_COMPARATOR: Placebo Comparator
20 subjects receiving oral placebo escitalopram and placebo SAM-3 daily in two divided doses.
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oral placebo escitalopram and oral placebo SAM-e daily in two divided doses.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hamilton Depression Scale
Time Frame: 12 weeks
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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
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alessandro Di Rocco, MD, NYU
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mood Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Depression
- Depressive Disorder
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
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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