Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine

Phase 2

• Conditions: Parkinson's disease; D010300

• Registration Number: JPRN-jRCTs061180028
• Lead Sponsor: Ando Rina

Brief Summary

We could not confirm the effect of duloxetine on pain as well as walking speed. Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson’s Disease Rating Scale Part III and 3 domains of the Parkinson’s Disease Questionnaire – 39.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-26
• Study Completion: 2019-08-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Male or Female, 20 years old or older
- Diagnosed with Parkinson's disease
- Having pain associated with PD and depression.
-Provide written informed consent signed by the subject

Exclusion Criteria

-Concomitant use of duloxetine within 2 weeks
-Subject with contraindication to duloxetine
-Suicidal ideation
-Renal transplantation or dialysis therapy
-History of any kidney diseases or baseline creatinine clearance below 30 (mL/min/1.73 m2)
-Woman who are pregnant or lactating
-Evidence of clinically significant disease
- Subjects on antipsychotics
-Have had multiple drug allergies or a severe drug reaction
-History of drug or alcohol dependency or abuse
-History of treatment with antipsychotics within 1 year before Visit 1
- Other inadequate status for clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analogue scale

Secondary Outcome Measures

Name	Time	Method
The short-form McGill Pain Questionnaire, Beck's Depression Scale, Parkinson's Disease Questionnaire-39, Unified Parkinson's Disease Rating Scale, Up and Go Test