E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027942 |
E.1.2 | Term | Mood depression |
E.1.2 | System Organ Class | 100000004873 |
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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 investigate the severity and duration of the depressive symptoms that are associated with a clinically important response (compared to placebo) to sertraline in people with depression |
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E.2.2 | Secondary objectives of the trial |
We will also investigate quality of life, the economic costs and whether emotional processing tasks are associated with response to treatment with sertraline. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age: 18-74 (inclusive) 2. Gender: both female and male 3. Depression presenting in primary care 4. Clinical equipoise about the benefits of SSRI medication 5. People who are having other interventions such as low intensity IAPT can also take part
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E.4 | Principal exclusion criteria |
1. Antidepressant medication in the preceding 8 weeks. 2. Unable to read, understand and/or complete questionnaires 3. Other psychiatric disorders: psychosis, schizophrenia, bipolar disorder, mania, hypomania, dementia, eating disorder. 4. Major alcohol or substance misuse problems 5. Currently on contraindicated medication: monoamine oxidase Inhibitors within the past 14 days or pimozide. 6. Patients with poorly controlled epilepsy 7. Known allergies to the IMP, placebo or excipients 8. Concurrent enrolment in another IMP trial 9. Women who are currently pregnant or planning pregnancy or lactating 10. Severe hepatic impairment 11 Bleeding disorders such as such as haemophilia, Christmas disease and von Willebrands disease, as well as those with past medical history of bleeding gastric or duodenal ulcers or other significant bleeding disorders |
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E.5 End points |
E.5.1 | Primary end point(s) |
PHQ 9 questionnaire as a continuous score |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Depressive symptoms with the PHQ9 at 2 & 12 weeks as a continuous outcome and 2, 6 & 12 weeks as a binary outcome. BDI-II as an alternative measure of depressive symptoms as continuous and binary at all follow up points. Anxiety symptoms measured using the GAD7 as a continuous and binary measure at all follow-up points. Quality of life assessed using the EQ5D and SF12. Economic costs associated with the treatment. Emotional processing tasks at 2 and 6 weeks.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
PHQ9, BDI-II and GAD7, EQ5D and SF12 at 2, 6 and 12 weeks. Emotional processing tasks at 2 and 6 weeks |
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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 | No |
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 | 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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 5 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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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The end of the trial will occur when the data analysis is complete |
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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 | 7 |
E.8.9.1 | In the Member State concerned days | 13 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 13 |