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Clinical Trial, Phase II, randomized, double-blind, placebo-controlled, 1-way over with 2 treatment periods of 40 weeks duration.Applicants: Research Group CTS546. IBIMA. Regional University Hospital. Málaga.Subjects: Patients above 55 years with depressive disorders.

Conditions
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.
MedDRA version: 17.0Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Registration Number
EUCTR2013-004276-35-ES
Lead Sponsor
Hospital Regional Universitario. IBIMA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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