This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.S-adenosyl-L-methionine (SAM-e) has been used in Europe for about 30 years for the treatment of depression. A number of small studies have suggested that this compound may have a use as either a primary treatment or an add-on in the treatment of Parkinson's disease. The primary aims of this study are to establish the safety and efficacy SAM-e in the treatment of depression associated with Parkinson's disease and to compare its safety and antidepressant effect with escitalopram (Lexapro), a standard SSRI antidepressant. The expectation, based upon a small open-label trial, is that SAM-e will be approximately equivalent in efficacy and tolerability to escitalopram. This will be conducted as a prospective, randomized, double-blind, double-dummy, controlled comparative study of SAM-e (1200 or 2400 mg per day) with escitalopram (10 or 20 mg per day) and placebo. Subjects will be treated for an initial period of 12 weeks double-blind, at which point they will be evaluated and offered the opportunity of continuing in a single-blind 12-week continuation phase. If the patient's condition has improved, he will be continued in the same arm, but if the depression failed to improve in the initial period, he will be placed on SAM-e if he was on either the placebo or escitalopram arm. If the patient had been on the SAM-e arm and failed to improve, he will be placed on escitalopram for the ensuing 12 weeks. In addition, blood will be drawn to type the common genetic polymorphisms encoding the various enzymes of the transmethylation pathways and to determine if these are associated with the clinical effect of S-adenosyl-L-methionine. The investigators will also determine whether S-adenosyl-L-methionine treatment affects the motor and nonmotor manifestations of Parkinson's disease as measured by standardized scales and whether or not the clinical effect is associated with changes in the serum concentrations of metabolites of the trans-methylation pathways.

National Institute of Health (NIH)
National Center for Research Resources (NCRR)
General Clinical Research Centers Program (M01)
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New York University
Internal Medicine/Medicine
Schools of Medicine
New York
United States
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