CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 115 enrolled
Drug / intervention
paroxetine +2 moredrug
Likely dose
Paroxetine 10–60 mg daily or Venlafaxine XR 37.5–300 mg daily (titrated as tolerated); or matching placeboAI-extracted
Key inclusion· 3
  • Age 30 years or older
  • Diagnosed with Parkinson's disease
  • Experiencing depressive symptoms (sadness, decreased energy, or sleep problems)
Key exclusion· 0

None specified.

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

Search/NCT00086190
NCT00086190Phase 3Completed

Study of Antidepressants in Parkinson's Disease

University of Rochester·interventional·Posted Jun 29, 2004·Updated Jan 4, 2013

In Brief

A Phase 3 clinical trial evaluating paroxetine, venlafaxine, and 1 other intervention for Parkinson Disease and Depression. Completed, enrolled 115 participants across 18 sites in 3 countries.

Detailed Summary

The purpose of this study is to find out if two antidepressant medications, paroxetine and venlafaxine, can help control depression in Parkinson's disease, and if these medications affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and balance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Puerto Rico, United States

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 29, 2004
Enrollment StartJun 1, 2005
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 22.0 years ago

Interventions

paroxetinedrug

Paroxetine 10 mg tablets or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated). Dosage for this study will not exceed 40 mg.

venlafaxinedrug

Venlafaxine XR 37.5 mg capsules or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the venlafaxine XR capsules or matching placebo will be increased to 75 mg followed by 75 mg increments every 2 weeks (if tolerated). Dosage for this study will not exceed 225 mg.

placeboother

an inactive substance