SAM-e for the Treatment of Depression in Patients With Parkinson's Disease
Parkinson's Disease, Depression
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinsons Disease, Depression, SAM-e
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
Sites / Locations
- New York University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
SAM-e
Escitalopram
Placebo Comparator
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.