E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Individuals with moderate to severe depression according to ICD-10 criteria. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
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 object of this trial is to estimate the effect of folate augmentation in new or continuing treatment of depressive disorder in primary and secondary care. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to evaluate the cost-effectiveness of folate augmentation of antidepressant treatment, investigate how the response to antidepressant treatment depends on genetic polymorphisms relevant to folate metabolism and antidepressant response, and explore whether baseline folate status can predict response to antidepressant treatment. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Translation and Validation study of a Welsh Language Version of the Beck Depression Inventory-II. 22nd June 2008 Version 3
Objective: To translate and validate the Welsh Language Version of the Beck Depression Inventory-II (BDI-II). This sub-study will involve inviting Welsh speaking participants to complete the Welsh Language version of the BDI-II at the end of the randomisation appointment (second visit). This study aims to test the Welsh language version to make sure it measures symptoms of depression as well as the English Language version. |
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E.3 | Principal inclusion criteria |
Only patients aged 18 or over with an ICD-10 diagnosis of moderate to severe depression [confirmed by the trial psychiatrists during the screening interview using the Beck Depression Inventory (BDI)] will be included. Only patients able to give informed consent (not delirious, actively psychotic or with severe communication or learning disability) and able to complete the research assessments will be included. |
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E.4 | Principal exclusion criteria |
Patients will be excluded from the study if they (a) are folate deficient:they cannot be randomised because they need to be treated with folic acid but can be included in the comprehensive cohort (b) are B12 deficient: they cannot be randomised because they need to be treated with B12 injections but can be included in the comprehensive cohort (c) have knowingly taken supplements containing folic acid within 2 months because this will mask any effects of folic acid given during the study (d) suffer from psychosis because additional treatment for psychosis may mask any benefit of folic acid with antidepressants. Plus people suffering from psychosis are less able to give informed consent and will require referral through to secondary services. (e) suffer from bipolar disorder (f) are already participating in another research project (g) are pregnant or planning to become pregnant as it is important for pregnant women to take folic acid so they cannot be randomised to placebo (h) are taking anticonvulsants as in very rare circumstances folic acid can react with certain anticonvulsants (i) serious, advanced or terminal illness with a life expectancy of less than 1 year (j) have recently started treatment for a medical condition which has not yet been stabilised (k) have had a diagnosis or treatment for any malignant disease or any related condition such as intestinal polyposis
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is to demonstrate a significantly meaningful difference on the Beck Depression Inventory (BDI) for individuals taking folic acid 5mg as a supplement to antidepressant therapy over and above that observed for those taking the placebo. |
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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 | 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 | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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.8.3 |
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 | 3 |
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 | 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 Trial Steering Committee will decide if there is a need to stop the trial on advice from the Data Monitoring and Ethics Committee following a gross imbalance in incidence of reported Serious Adverse Events. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |