A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression.

A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression. - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016893

Enrollment

Registered

2015-04-01

Start date

2014-09-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PD patients

Interventions

The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). Dur

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Diagnosed with Parkinson's disease - Having pain associated with PD and depression. -Provide written informed consent signed by the subject

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Visual analogue scale	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactHirotaka Iwaki

Ehime University Hospital Dept. of Clinical pharmacology and Neurology

h-iwaki@m.ehime-u.ac.jp089-960-5095

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson&#39;s disease with depression.