SAM-e for the Treatment of Depression in Patients With Parkinson's Disease

Phase 2

Completed

• Conditions: Parkinson's Disease; Depression
• Interventions: Drug: oral escitalopram; Drug: placebo; Drug: SAM-e

• Registration Number: NCT00070941
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2003-10-09
• Study First Submitted QC: 2003-10-10
• Study First Posted: 2003-10-13
• Primary Completion: 2010-06
• Study Completion: 2010-10
• Results First Submitted: 2013-05-03
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-02
• Last Update Submitted: 2016-06-02
• Results First Posted: 2016-07-13
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Escitalopram	oral escitalopram	40 subjects receiving oral escitalopram 20mg or 40 mg daily, in two divided doses, and placebo SAM-e.
Placebo Comparator	placebo	20 subjects receiving oral placebo escitalopram and placebo SAM-3 daily in two divided doses.
SAM-e	SAM-e	40 subjects receiving oral SAM-e, 1200mg or 1800mg daily in two divided doses, and placebo escitalopram.

Primary Outcome Measures

Name	Time	Method
Change in Hamilton Depression Scale	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.)

Trial Locations

Locations (1)

New York University; 🇺🇸 New York, New York, United States