E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Depression as defined by fulfilled ICD-10 criteria for diseases F32.1-3, F33.1-3. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
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 investigate whether or not outpatients with depression (as defined by ICD-10 criteria for F32.1-3, F33.1-3) and a plasma concentration of 25-hydroxy-vitamin D3 below 100 nmoles per liter can benefit from vitamin D supplementation regarding their depression.
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E.2.2 | Secondary objectives of the trial |
To investigate whether or not there is a correlation between the severity of symptoms in outpatients with depression (as defined by ICD-10 criteria for F32.1-3, F33.1-3) and the plasma concentration of 25-hydroxy-vitamin D3.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Depression as defined by fulfilled ICD-10 criteria for diseases F32.1-3, F33.1-3.
Age between 18 and 75 years (both included).
Admission not required at the time of inclusion.
Secure contraception in women of childbearing potential. |
|
E.4 | Principal exclusion criteria |
Fulfilled ICD-10 criteria for diseases F20-29, F30-31 or change of principal diagnosis during the study.
Sarcoidosis.
Tuberculosis.
Increased plasma ionized calcium concentration above 1,40 mmoles per liter.
Increased plasma phosphate concentration above 1,50 mmoles per liter for women, above 1,60 mmoles per liter for men below 50 years of age and above 1,35 mmoles per liter for men equal to and above 50 years of age.
Plasma concentration of 25-hydroxy-vitamin D3 below 5 nmoles per liter or above 100 nmoles per liter.
Pregnancy or wanted pregnancy.
Nursing women.
Already participated in the trial.
Daily intake of vitamin D3 above 10 mikrograms.
Allergy towards tablet contents.
Not received electroconvulsive treatment within the last 6 months.
No informed consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Major Depression Inventory (MDI) score.
Hamilton-6 score.
World Health Organization Five Well-Being Index (WHO-5) score.
Plasma concentration of 25-hydroxy-vitamin D3. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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.8.3 |
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 | 4 |
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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Provided in the protocol. |
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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 | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |