SAM-e for the Treatment of Depression in Patients With Parkinson's Disease
|Parkinson's Disease Depression||Drug: SAM-e Drug: oral escitalopram Drug: placebo||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||SAM-e Treatment of Depression in Parkinson's Disease.|
- Change in Hamilton Depression Scale [ Time Frame: 12 weeks ]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.)
|Study Start Date:||July 2003|
|Study Completion Date:||October 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
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 Name: 1 Experimental
Active Comparator: Escitalopram
40 subjects receiving oral escitalopram 20mg or 40 mg daily, in two divided doses, and placebo SAM-e.
Drug: oral escitalopram
20mg or 30mg daily in two divided doses, along with placebo SAM-e.
Placebo Comparator: Placebo Comparator
20 subjects receiving oral placebo escitalopram and placebo SAM-3 daily in two divided doses.
oral placebo escitalopram and oral placebo SAM-e daily in two divided doses.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070941
|United States, New York|
|New York University|
|New York, New York, United States, 10003|
|Principal Investigator:||Alessandro Di Rocco, MD||NYU|