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

JRCT ID: jRCTs061180028

Registered date:26/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 11/05/2015
• Target sample size: 50
• Study type: Interventional
• 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 Outcome: Visual analogue scale
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20 years old
• Age maximum: None
• Gender: Both

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

• Primary Sponsor: Ando Rina
• Source(s) of Monetary Support: SHIONOGI & CO., LTD.
• Secondary ID(s): UMIN000016893