E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The trial aims to treat depression. The incidence of major depression in the elderly accounts for between 3.6 and 4.8% and increases to 8 to 37.4% when depressive disorders in general is studied. Besides depression in the elderly presents with cognitive impairment, impaired physical and social functioning, and predisposes to suicide. These are patients who often have multiple conditions and be taking numerous psychopharmacological treatments which hinders further treatment. |
El ensayo pretende tratar la depresión. La incidencia de depresión mayor en el anciano supone entre un 3,6 y un 4,8% y aumenta hasta un 8-37,4% sí hablamos de trastornos depresivos en general. Además la depresión en el anciano cursa con deterioro cognitivo, deterioro del funcionamiento físico y social, y predispone al suicidio. Son pacientes que suelen presentar pluripatología y estar tomando numerosos tratamientos psicofarmacológicos lo que dificulta aún más su tratamiento.
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E.1.1.1 | Medical condition in easily understood language |
The trial aims to treat depression. The incidence of major depression in the elderly accounts for between 3.6 and 4.8% and increases to 8 to 37.4% when depressive disorders in general is studied. |
El ensayo pretende tratar la depresión. La incidencia de depresión mayor en el anciano supone entre un 3,6 y un 4,8% y aumenta hasta un 8-37,4% sí hablamos de trastornos
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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 | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012378 |
E.1.2 | Term | 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 |
Primary outcomes measurements: the improvement in neuropsychiatric symptoms through instruments BDI -IA ; GADS , GAD- 7; GHQ28 ; CGI and MEC- 30 at 0, 3 and 6 months during the trial. |
Resultados primarios mediciones: la mejora de los síntomas neuropsiquiátricos a través de instrumentos BDI-IA; Gads, GAD-7; GHQ28; CGI y MEC-30 a 0, 3 y 6 meses durante el juicio. |
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E.2.2 | Secondary objectives of the trial |
Secondary Outcome Measures: Levels of blood oxidative stress |
Las medidas de resultado secundarias: niveles de estrés oxidativo en sangre |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria:
• Diagnosis of mild depression smaller or larger by Mini International Neuropsychiatric Interview (MINI).
• Having more than 55 years old
• Have signed the informed consent document before you start participating in the trial. |
Criterios de inclusión:
• Diagnóstico de depresión menor o mayor leve mediante Mini International Neuropsychiatric Interview (MINI).
• Tener una edad mayor de 55 años
• Haber firmado el documento de consentimiento informado, antes de iniciar su participación en el ensayo. |
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E.4 | Principal exclusion criteria |
Exclusion criteria:
• Individuals with other psychiatric diagnosis as the first diagnosis.
• To have suffered serious medical problems in the last 12 months.
• Are taking more than 100mg of vitamin E or C a day in the last 4 months.
• Having physical, mental or sensory problems that prevent the assessment of effectiveness.
• Hypersensitivity to any component of the preparation.
• Previous pathology of kidney stones |
Criterios de exclusión:
• Se excluirán del estudio los individuos con otro diagnostico psiquiátrico como primer diagnóstico.
• Haber padecido problemas médicos serios en los últimos 12 meses.
• Estar tomando más de 100mg de vitaminas E o C al día en los últimos 4 meses.
• Tener problemas físicos, psíquicos o sensoriales que impidan la evaluación de la efectividad.
• Hipersensibilidad a alguno de los componentes del preparado.
• Antecedentes de patología de cálculos renales
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E.5 End points |
E.5.1 | Primary end point(s) |
12 weeks of treatment or serious adverse events |
12 semanas de tratamiento o efectos adversos serios. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
T0 = initial or baseline assessment,
T1: 2nd assessment after 12 weeks of treatment,
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T0= valoración inicial o basal,
T1: 2ª valoración tras 12 semanas de tratamiento,
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E.5.2 | Secondary end point(s) |
serious adverse events |
efectos adversos serios. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
T2: 3rd assessment after 24 weeks of treatment |
T2: 3ª valoración tras 24 semanas de tratamiento |
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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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
cruzado de una via |
one-way cross over |
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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 | 2 |
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 | No |
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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last visit of the patient after 24 weeks of treatment or serious adverse events |
ultima visita de ultimo paciente tras 24 semanas de tratamiento o por efectos adversos severos |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |