Depression Clinical Trial
Official title:
SAM-e Treatment of Depression in Parkinson's Disease
This study will test a chemical called s-adenosyl-methionine (SAM-e) for the treatment of depression in patients with Parkinson's disease (PD).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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