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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.

Phase II, Double-blind, randomized, 1-way cross-over, to investigate the effectiveness of the combination of ascorbic acid (vitamin C) and tocopherol (vitamin E) versus placebo for the treatment of depressive disorders in elderly

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-004276-35-ES
Enrollment
Unknown
Registered
2014-06-09
Start date
2014-10-10
Completion date
Unknown
Last updated
2014-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 17.0

Interventions

Product Name: ascorbic acid Pharmaceutical Form: Capsule INN or Proposed INN: ASCORBIC ACID Current Sponsor code: acido ascorbico Other descriptive name: vitamin C Concentration unit: mg milligram(s)

Sponsors

Hospital Regional Universitario. IBIMA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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. 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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: 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. ;Secondary Objective: Secondary Outcome Measures: Levels of blood oxidative stress;Primary end point(s): 12 weeks of treatment or serious adverse events;Timepoint(s) of evaluation of this end point: T0 = initial or baseline assessment, T1: 2nd assessment after 12 weeks of treatment,—

Secondary

MeasureTime frame
Secondary end point(s): serious adverse events;Timepoint(s) of evaluation of this end point: T2: 3rd assessment after 24 weeks of treatment—

Countries

Spain

Contacts

Public ContactYolanda de Diego

Hospital Regional Universitario. IBIMA

ydediego@yahoo.es34951290346

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026