Conditions: Parkinson's Disease Depression
Keywords: Parkinsons Disease Depression SAM-e
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 29
Healthy volunteers: no

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.

Arms:
arm 1: 40 subjects receiving oral SAM-e, 1200mg or 1800mg daily in two divided doses, and placebo escitalopram. arm 2: 40 subjects receiving oral escitalopram 20mg or 40 mg daily, in two divided doses, and placebo SAM-e. arm 3: 20 subjects receiving oral placebo escitalopram and placebo SAM-3 daily in two divided doses.

Interventions: intervention 1: SAM-e intervention 2: oral escitalopram intervention 3: placebo
Intervention descriptions: intervention 1: oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo escitalopram. intervention 2: 20mg or 30mg daily in two divided doses, along with placebo SAM-e. intervention 3: oral placebo escitalopram and oral placebo SAM-e daily in two divided doses.

Protocol document: