Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease

Lilly

Status and phase

Completed

Phase 4

Conditions

Idiopathic Parkinson Disease

Major Depressive Disorder

Treatments

Drug: Duloxetine hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00437125

F1J-IT-HMFQ (Other Identifier)

11127 (Registry Identifier)

Details and patient eligibility

About

This study aims to assess the tolerability of duloxetine, 60mg once daily, in open label fashion, in depressed patients with Parkinson's disease during 12 weeks treatment.

Enrollment

151 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Are outpatients, male or female, 30 through 75 years of age
Meet diagnostic criteria for major depression episode and a clinical diagnosis of idiopathic Parkinson's disease
Have a clinician-rated 17-item Hamilton Depression Rating Scale (HAMD17) total score greater than or equal to 15, a Beck Depression Inventory (BDI) total score greater than or equal to 13 and a Clinical Global Impression of Severity (CGI-S) score greater than or equal to 3 at both Visit 1 and Visit 2
Have satisfactory cognitive function
Have been held on stable dosage of antiparkinsonian medications for at least 4 weeks immediately prior to Visit 1

Exclusion criteria

Any current primary psychiatric diagnosis other than Major depressive episode, and any personality disorder that could interfere with the compliance with the study protocol
Atypical or secondary parkinsonism due to drugs or diseases with features of Parkinson's disease
Motor conditions for which it is to be expected to change the antiparkinsonian treatment during the course of the study
Clinically significant laboratory abnormalities or serious, unstable medical illness
Lack of response of current episode to two or more adequate courses of antidepressant therapy