E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major depressive disorder (episode or recurrent), moderately severe as principal DSM-IV diagnosis. |
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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 | 10012378 |
E.1.2 | Term | 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 is assessing the depressive symptom reduction rate of mono-treatment (PST) compared to combined treatment (PST and duloxetine) in patients with major depressive disorder. In other words, testing the hypothesis that combined treatment is more effective than mono-treatment in patients with major depressive disorder. |
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E.2.2 | Secondary objectives of the trial |
1. are there intervening variables such as somatic symptoms that interact with the treatment condition? 2. temporal relationship between the reduction of depressive symptoms and somatic symptoms. 3. does providing a structured way of assisting patients with their difficulties by PST will enhance adherence to pharmacotherapy (see protocol) 4. does PST will enhance of the sense of mastery and coping in MDD patients ? 5. do other characteristics, such as demographic variables, depression characteristics (severity and duration) and co morbidity predict a different outcome for either treatment condition. 6. what are the effects of the interventions on symptom reduction rates and the quality of life 12 months after the beginning of the treatment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
PHQ-9 > 9 (first screening)
actual screening Principal DSM-IV diagnosis: major depressive disorder (episode or recurrent), moderately severe. IDS-SR30 score > 22 Age 18-65
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E.4 | Principal exclusion criteria |
Too ill, according to GP’s judgement immediate start treatment or transfer to outpatient department is necessary. Indication for immediate crisis intervention or hospital admittance due to e.g severe suicidal risk, serious suicidality or severe psychotic symptoms Medical contraindications for duloxetine Use of antipsychotic medication or mood stabilizers Drug abuse or dependence in the past six months Current use of any hard drug or cannabis (more than 3 units a week) More than 4 units of alcohol per day Pharmacological drugs that influence psychic functions Pregnancy and breast feeding Use of St John's worth (hypericum perforatum) Inability to participate in case of to severe language barrier Patient follows psychotherapy
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E.5 End points |
E.5.1 | Primary end point(s) |
50% reduction at IDS-SR30 score from baseline to study periods’ endpoint |
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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 | No |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
problem solving treatment (PST) WITHOUT pharmacotherpeutic addition |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |