NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061180028

Registered date:26/02/2019

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedParkinson's disease
Date of first enrollment11/05/2015
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule.

Outcome(s)

Primary OutcomeVisual analogue scale
Secondary OutcomeThe short-form McGill Pain Questionnaire, Beck's Depression Scale, Parkinson's Disease Questionnaire-39, Unified Parkinson's Disease Rating Scale, Up and Go Test

Key inclusion & exclusion criteria

Age minimum20 years old
Age maximumNone
GenderBoth
Include 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
Exclude 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

Related Information

Contact

Public contact
Name Hirotaka Iwaki
Address Shitsukawa 454, Toon, Ehime Ehime Japan 7910295
Telephone +81-899605095
E-mail h-iwaki@m.ehime-u.ac.jp
Affiliation Ehime University
Scientific contact
Name Rina Ando
Address Sitsukawa 454, Toon, Ehime Ehime Japan 791-0295
Telephone +81-89-960-5095
E-mail ando.rina.cn@ehime-u.ac.jp
Affiliation Ehime University Hospital