E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major depressive disorder |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057840 |
E.1.2 | Term | Major depression |
E.1.2 | System Organ Class | 10037175 - 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 |
To compare the efficacy of vortioxetine (10 to 20 mg/day) versus desvenlafaxine (50 mg/day) after 8 weeks of treatment, on depressive symptoms in patients with major depressive disorder (MDD) who have responded partially to monotherapy with a SSRI |
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E.2.2 | Secondary objectives of the trial |
To compare the efficacy of vortioxetine (10 to 20 mg/day) versus desvenlafaxine (50 mg/day) after 8 weeks of treatment on: - Cognitive functioning - Reward motivation - Functioning - Health-Related Quality of life (HRQoL) - Global clinical impression (CGI) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- The patient has a primary diagnosis of single or recurrent MDD, diagnosed according to DSM-5®. The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (MINI). - The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥24 at screening and baseline. - The patient has had the current MDE for ≥3 months and < 12 months. - The patient has been treated with an SSRI as monotherapy (citalopram, escitalopram, paroxetine, sertraline) for at least 6 weeks at licensed dose for the current MDE and with a partial response and is a candidate for a switch in the investigator’s opinion. - The patient wants to switch antidepressant treatment. Other inclusion criteria may apply. |
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E.4 | Principal exclusion criteria |
- The patient has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance. Other exclusion criteria may apply. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Time-frame: From baseline to Week 8 |
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E.5.2 | Secondary end point(s) |
2. Remission (defined as a MADRS total score =<10) 3. Response (defined as a => 50% decrease from baseline in MADRS total score) 4. Change in MADRS anhedonia factor score 5. Change in Digital Symbol Substitution Test (DSST) total score 6. The proportion number of Hard Choice/number of High Reward trials and number of Low choice/number of Low Reward trials when performing the Effort- Expenditure for Rewards Task (EEfRT) 7. Change in Clinical Global Impression - Severity of Illness (CGI-S) score 8. Clinical Global Impression Scale- Global Improvement (CGI-I) score 9. Change in Functioning Assessment Short Test (FAST) total score 10. Change in FAST sub-domain scores 11. Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score 12. Change in Q-LES-Q work subscale 13. Change in Q-LES-Q household duties subscale 14. Change in Q-LES-Q school/course subscale 15. Change in Q-LES-Q leisure time activities subscale 16. Change in Q-LES-Q social relations subscale. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2. Time-frame: At Week 8 3. Time-frame: At Week 8 4. Time-frame: From baseline to Week 8 5. Time-frame: From baseline to Week 8 6. Time-frame: From baseline to Week 8 7. Time-frame: From baseline to Week 8 8. Time-frame: At Day 7,28,56 9. Time-frame: From baseline to Week 8 10. Time-frame: From baseline to Week 8 11. Time-frame: From baseline to Week 8 12. Time-frame: From baseline to Week 8 13. Time-frame: From baseline to Week 8 14. Time-frame: From baseline to Week 8 15. Time-frame: From baseline to Week 8 16. Time-frame: From baseline to Week 8 |
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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 | No |
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) | 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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Placebo will be used during the safety follow-up after the 8-week treatment period. |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 75 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Belgium |
Bulgaria |
Croatia |
Czechia |
Finland |
France |
Latvia |
Mexico |
Russian Federation |
Slovakia |
Spain |
Sweden |
Ukraine |
Estonia |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 11 |
E.8.9.2 | In all countries concerned by the trial days | 20 |