E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major Depression Disorder associated with painful physical symptoms |
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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 | LLT |
E.1.2 | Classification code | 10057840 |
E.1.2 | Term | Major depression |
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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 the study is to to asses the percentage of responders at week 5 with a combined reduction score of Pain (VAS ≥ 50%) and Depression (HAM-D ≥ 50%). |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of the study are: To evaluate the Percentage of responders at week 7 and at week 9 defined by a reduction of ≥ 50 % in the HAM-D score and with a reduction of ≥ 50 % in the VAS score To evaluate the Safety of Trazodone in doses up to 450 mg To evaluate the pain disability compared to baseline and between Responders and Non-Responders To evaluate the pain perception compared to baseline and between Responders and Non-responders To evaluate the Quality of sleep compared to baseline and between Responders and Non-Responders To evaluate the most effective dose in relation to Depression and Pain To evaluate the amount/consumption of rescue medication To evaluate the course of depression measured by HAM-D compared to baseline To evaluate the course of pain measured by VAS compared to baseline
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subject diagnosed Major Depression associated with painful physical symptoms, and fulfilling the following criteria:
Concerning Painful physical symptoms: at least 1 month prior to study start presence of PPS. Global Pain m assessed by the patient must correspond to ≥ 60 mm VAS at Visit 2.
Concerning Major Depression: at least 1 month prior to study start diagnosis of Major Depression according to DSM-IV criteria Score 18 – 24 on the Hamilton Depression Rating Scale at Visit 2. Male or female outpatients aged 18-65 years
If female of childbearing potential: must have negative (urine) pregnancy test at screnning visit and at Visit 5. Subject who, in the opinion of the investigator, would understand the meaning of the information sheet, would be co-operative and sufficiently reliable to use the medication as instructed, complete the diary and return for follow-up visits. Subject has provided written informed consent prior to undergoing any study procedure.
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E.4 | Principal exclusion criteria |
Subjects will be excluded from the study for any of the following reasons: Who is pregnant or breast-feeding. Who has a known hypersensitivity to trazodone, Who is suffering from known liver, kidney, cardiovascular, pulmonary or hematological disease Who is suffering from asthma. Who is suffering from cardiac malfunction Who is suffering from epilepsy Who is suffering from hypotension i.e. systolic blood pressure < 100 mm Hg Who is suffering from hypertension i.e. diastolic > 90 mm HG or systolic > 140 mm HG Who is suffering from bradycardia with a frequency < 45 Who has suffered from an ulcer, gastrointestinal bleeding and/or perforation within 2 years prior to the trial. With evidence or history of drug or alcohol abuse. Who has previously participated in this clinical study or any other clinical study in the past 30 days With mental impairment limiting the ability to comply with study requirements Who, in the opinion of the investigator, is unable or unwilling to complete the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of responders at week 5 defined by a reduction of at least 50 % in the HAM-D score and with a reduction of at least 50 % in the VAS score |
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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 | No |
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 | Yes |
E.6.10 | Pharmacogenetic | No |
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) | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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) | No |
E.8.2.2 | Placebo | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
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 | No |
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 | |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 15 |