Phase 4 N=55 Randomized Double-blind Treatment

Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease

Depressive Disorder · Parkinson Disease

Bottom Line

View on ClinicalTrials.gov: NCT00304161 ↗

Enrolled (actual)

Serious AEs

7.3%

Results posted

Mar 2015

Primary outcome: Primary: Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale — 22.7; 9.5 percentage of improved participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Atomoxetine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale	22.7; 9.5	—
SECONDARY Clinical Global Impression-Improvement Scale	45.5; 33.3	—

Summary

This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease.

Eligibility Criteria

Inclusion Criteria

Diagnosis of idiopathic Parkinson's disease
IDS score greater than 21
Mini-Mental State Examination (MMSE) score greater than 15

Exclusion Criteria

Recent deep brain stimulation
Currently participating in an antidepressant trial at a less than adequate dose and duration
Severe depression or depression with suicide ideation
History of liver toxicity
Unstable medical disease or comorbid psychiatric disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00304161). 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.