E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Depressed patients (according to DSM-IV criteria) experiencing painful physical symptoms |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Information not present in EudraCT |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the efficacy of Duloxetine 60mg once daily versus placebo over an 8-week treatment period, on somatic complaints of pain, as measured by the Brief Pain Inventory Short Form (BPI-SF) "average pain" question, in subjects meeting criteria for Major Depressive Disorder (as defined in the Diagnosis and Statistical Manual of Mental Disorders, Fourth Edition) |
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E.2.2 | Secondary objectives of the trial |
• Montgomery-Asberg Depression Rating Scale (MADRS) total score • Time to sustained clinical response for Painful Physical Symptoms • Time to sustained clinical response for overall depression symptoms • Patient rated SCL-90R scale • Patient rated PGI-improvement scale • Physician rated CGI-severity scale • Physician rated CGI-improvement scale • Severity and interference scores of the BPI-SF • Safety parameters |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Outpatients, aged 18 years or older at screening visit, who meet criteria for major depressive disorder, according to the DSM-IV criteria and confirmed by MINI • MADRS total score = or more than 20 at screening and baseline visits (V1 & V2) • Painful Physical Symptoms with a score = or more than 3 on the BPI-SF scale for average pain at V1 & V2 • CGI-Severity score = or more than 4 at V1 & V2 • Written informed consent at V1
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E.4 | Principal exclusion criteria |
• Lack of response of the current episode to two or more adequate courses of antidepressant therapy • Any anxiety disorder as a primary diagnosis < 6 months • Any diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders • Any Axis II disorders • History of serious suicide attempt or current serious suicidal risk and / or score > 2 on question 10 (suicide) of the MADRS • History of drug dependence, including alcohol or benzodiazepines < 1 year • Patients requiring continuously analgesics (> step 2 WHO definition) because of chronic pain (> 6 months) • Patients with organic pain syndromes • Epilepsy or history of seizure disorder or of a treatment with anticonvulsant medication • Known diagnosis of raised intraocular pressure or risk of acute narrow-angle glaucoma • Known diagnosis of congenital galactosaemia, glucose or galactose malabsorption syndrome, or lactose deficiency • Severely impaired renal function (creatinine clearance <30 mL/min) • Acute liver injury (such as hepatitis) or severe (Child-Pugh Class C) cirrhosis • Women who are pregnant or breast-feeding or of childbearing potential not using medically accepted means of contraception • Participation in another clinical trial < 30 days prior to V1 • Previous use of Duloxetine (including study investigating Duloxetine) • Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to V2 or potential need to use a MAOI within 5 days after discontinuation of study drug • Treatment with fluoxetine within 28 days prior to V2 • Frequent and/or severe allergic reactions with multiple medications. Known hypersensitivity to Duloxetine or any of the inactive ingredients • Electro-convulsive Therapy (ECT) or Transcranial Magnetic Stimulation (TMS) within one year prior to V1 • Initiation or discontinuation of depression-oriented psychotherapeutic treatment within 6 weeks prior to V1 or planned use of such treatment at any time during the study
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in BPI-SF "average pain" question score from baseline over the 8 weeks of treatment |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | Yes |
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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Last visit last patient planned date = 10 May 2006 |
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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 | |
E.8.9.1 | In the Member State concerned months | |
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 | 4 |