CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 29 enrolled
Drug / intervention
SAM-e +2 moredrug
Likely dose
SAM-e 1200 mg or 1800 mg daily in two divided doses, or escitalopram 20 mg or 30 mg daily in two divided dosesAI-extracted
Key inclusion· 5
  • ✓Idiopathic Parkinson's disease with at least two cardinal features: resting tremor, rigidity, bradykinesia, or postural reflex impairment
  • ✓Stable anti-parkinson medication regimen with no changes in the 4 weeks before study entry
  • ✓No antidepressant or antipsychotic medications in the 30 days before study entry
  • ✓Adequate cognition: Mini-Mental Status Exam score >24
Key exclusion· 8
  • ✕Secondary Parkinsonism from drugs, metabolic disorders, cerebrovascular disease, encephalitis, or other degenerative diseases
  • ✕History of bipolar disorder, hypomania, mania, schizophrenia, or other psychotic disorder
  • ✕Serious suicidal attempt in the past 12 months or current serious suicidal tendencies/potential
  • ✕Use of monoamine oxidase inhibitors (including selegiline) within 6 weeks before study entry

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00070941
NCT00070941Phase 3Completed
CompareCT.gov

SAM-e Treatment of Depression in Parkinson's Disease.

NYU Langone Health·interventional·Posted Oct 13, 2003·Updated Jul 13, 2016

In Brief

A Phase 3 clinical trial evaluating SAM-e, oral escitalopram, and 1 other intervention for Parkinson's Disease and Depression. Completed, enrolled 29 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease, Depression
CountriesUnited States
CollaboratorsNational Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 13, 2003
Enrollment StartJul 1, 2003
Primary CompletionJun 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 22.7 years ago

Interventions

SAM-edrug

oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo escitalopram.

oral escitalopramdrug

20mg or 30mg daily in two divided doses, along with placebo SAM-e.

placebodrug

oral placebo escitalopram and oral placebo SAM-e daily in two divided doses.