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Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

An Open Label Pilot Study on the Tolerability of Duloxetine in the Treatment of Depressed Patients With Parkinson's Disease

NCT00437125•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

30 - 75 years

Sex

ALL

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

Locations (13)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ancona, Italy

Brescia, Italy

Catania, Italy

Genova, Italy

Lido di Camaiore, Italy

Messina, Italy

Milan, Italy

Naples, Italy

Padua, Italy

Pisa, Italy

Key Dates

Start Date

March 1, 2007

Primary Completion Date

July 1, 2009

Completion Date

July 1, 2009

Last Updated

September 8, 2010

Enrollment

151

ACTUAL participants

Conditions

Major Depressive DisorderIdiopathic Parkinson Disease

Interventions

Duloxetine hydrochloride

DRUG

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 8, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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