Phase 2
N=52
Treatment of Depression in Parkinson's Disease Trial
Parkinson Disease · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00062738 ↗Enrolled (actual)
52
Serious AEs
5.8%
Results posted
Mar 2013
Primary outcome: Primary: Hamilton Depression Scale — 10.84; 12.45; 15.81 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- paroxetine (Drug); Nortriptyline (Drug); placebo (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Depression Scale |
10.84; 12.45; 15.81 | — |
| SECONDARY Percent Responders |
53; 11; 24 | <.05 sig |
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.
Eligibility Criteria
inclusion criteria
- Parkinson's disease without dementia.
- Depression.
- Males or females.
exclusion criteria
- Psychosis
- Heart block
Data sourced from ClinicalTrials.gov (NCT00062738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.