At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 52 enrolled
Drug / intervention
paroxetine +2 moredrug
Likely dose
Paroxetine CR 12.5–25 mg once daily at bedtime or Nortriptyline 25–75 mg once daily at bedtimeAI-extracted
Key inclusion· 2
- ✓Diagnosis of Parkinson's disease without dementia
- ✓Clinical depression
Key exclusion· 2
- ✕Active psychosis
- ✕Heart block
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Depression in Patients With Parkinson's Disease
In Brief
A Phase 2 clinical trial evaluating paroxetine, Nortriptyline, and 1 other intervention for Parkinson Disease and Depression. Completed, enrolled 52 participants across 1 site.
Detailed Summary
The goal of this study is to evaluate the effectiveness and safety of two antidepressants--nortriptyline and paroxetine, compared to placebo in patients with Parkinson's disease and depression.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease, Depression
CountriesUnited States
CollaboratorsGlaxoSmithKline
Timeline
Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2003
First PostedJun 2003
Primary CompletionJan 2009
TodayJul 2026
First PostedJun 13, 2003
Enrollment StartJun 1, 2003
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 23.1 years ago
Interventions
paroxetinedrug
Paroxetine CR 12.5 - 25 mg q hs
Nortriptylinedrug
nortriptyline 25 - 75 mg q hs
placeboother
matching placebo