An open label pilot study on the tolerability of duloxetine in the treatment of depressed patients with Parkinson s disease - ND

• Conditions: outpatient; MedDRA version: 9.1Level: SOCClassification code 10037175Term: Psychiatric disorders

• Registration Number: EUCTR2006-006043-32-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients are eligible to be included in the study only if they meet all of the following criteria 1 Are outpatients, male or female, 30 through 75 years of age. 2 Meet DSM-IV-TR diagnostic criteria for major depression episode, as defined in Section 4.1.1 Disease Diagnostic Criteria , at both Visit 1 and Visit 2, confirmed by the MINI Depression Module. 3 Have a clinician-rated HAMD17 total score 61619; 15, a BDI total score 8805; 13 and a CGI-S score 61619; 3 at both Visit 1 and Visit 2. 4 Have a clinical diagnosis of idiopathic Parkinson s disease according to the United Kingdom Parkinson s Disease Society Brain Bank Criteria. UK PD SBBC with a disease stage of 1 to 3 on the Modified Hoehn and Yahr Staging Scale see Section 4.1.1 . 5 Have satisfactory cognitive function as indicated by a score of at least 24 on the Mini Mental State Examination MMSE total score. 6 Have been held on stable dosage of antiparkinsonian medications for at least 4 weeks immediately prior to Visit 1. 7 Have an educational level, language fluency, and degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator. 8 Are judged to be reliable and agreeable to keeping all appointments for clinic visits, tests, and procedures required by the protocol. 9 Are able to swallow capsules.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from the study for any of the following reasons 10 Any current primary DSM-IV Axis I diagnosis other than Major Depressive Episode. 11 The presence of an Axis II disorder which, in the judgment of the investigator, would interfere with compliance with the study protocol. 12 Atypical or secondary parkinsonism due to drugs or diseases with features of Parkinson s disease such as progressive supranuclear palsy, essential tremor, multiple system atrophy, striatonigral degeneration, olivopontocerebellar atrophy, or postencephalitic parkinsonism . 13 Motor conditions for which it is to be expected to change the antiparkinsonian treatment during the course of the study. 14 Patients judged by the investigator to be at serious suicidal risk, and/or patient with a HAMD17 score on Item 3 Suicide 8805; 3 at both Visit 1 and Visit 2. 15 Clinically significant laboratory abnormalities or serious, unstable medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic disease such that hospitalization for the disease is anticipated within 3 months or death is anticipated within 3 years. Patients diagnosed with and/or treated for hyper- or hypothyroidism may be enrolled if they have been on a stable dose of thyroid supplement for the past 6 months and are chemically euthyroid. 16 Liver disease resulting in hepatic impairment acute hepatic injury, such as hepatitis; moderate, Child-Pugh class B, hepatopathy or severe renal impairment. 17 Narrow Angle Angle-Closure Glaucoma 18 Use of Excluded Medications listed in Protocol Attachment HMFQ.2. 19 Use of fluoxetine within 30 days prior to Visit 1, monoamine oxidase inhibitor MAOI within 2 weeks prior to Visit 1, or other excluded medication within 1 week prior to Visit 1. 20 Potential need to use an MAOI within 5 days of discontinuation of treatment, the likelihood of which will be based on a patient s previous treatment history. 21 Frequent and/or severe allergic reactions with multiple medications or known allergic reactions to the study drugs. 22 Concomitant use of potent inhibitors of CYP450 2D6 and 1A2. 23 Electroconvulsive therapy ECT within the past year 24 Women of child-bearing potential who are not using a medically accepted means of contraception e.g., abstinence, intrauterine device, oral contraceptive, implant, Depo-Provera, or barrier devices . Women who are pregnant or breast-feeding may not participate in the study. 25 Patients who have received treatment within the last 30 days with a drug that has not received regu

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the tolerability of duloxetine 60 mg once daily QD , given in an open label fashion, in the treatment of depression in patients with PD, after 12 weeks treatment.;Secondary Objective: Data will be analyzed separately for the following secondary objectives Evaluate safety and tolerability of duloxetine in the study population Assess the efficacy of duloxetine in treating depressed patients with Parkinson Disease Evaluate the effect of duloxetine on the quality of life in the study population Investigate the effect of duloxetine on the sleep pattern of depressed patients with Parkinson Disease Evaluate the differences in efficacy and safety due to time of administration in the study population;Primary end point(s): Duloxetine will be well tolerated at the end of the study if the discontinuation rate from baseline to endpoint will be not superior to 19 .