E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10037175 |
E.1.2 | Term | Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 . |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |