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 disordersTherapeutic 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
• 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
• 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
Name Time Method
- Secondary Outcome Measures
Name Time Method