The TRUST Study - Depression Substudy

• Status: Completed
• Trial end date: 2018-04-05
• Target enrollment: 0
• Participant gender: All

Summary

Mild thyroid failure is a common condition among older adults and has been associated with numerous adverse effects on health, such as cardiovascular disease, cognition disturbances and muscular problems. Mild thyroid failure has also been associated with an increased risk of developing depression. To date, only few studies have investigated the effect of thyroid hormone replacement on depression in patients with mild thyroid failure. This study therefore aims to assess whether thyroid hormone replacement in older adults with mild thyroid failure is associated with a decrease in the presence of depressive symptoms. This study forms a substudy of a large international study on thyroid hormone replacement in older adults with mild thyroid failure (the TRUST study).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborators: Leiden University Medical Center; University of Bern
• Treatments: Carboxymethylcellulose Sodium

Criteria

Inclusion Criteria:

• Community-dwelling patients aged >= 65 years with subclinical hypothyroidism

• Written informed consent

Exclusion Criteria

• Subjects currently on Levothyroxine or antithyroid drugs, amiodarone or lithium

• Recent thyroid surgery or radio-iodine (within 12 months)

• Grade IV NYHA heart failure

• Prior clinical diagnosis of dementia

• Recent hospitalisation for major illness or elective surgery (within 4 weeks)

• Terminal illness

• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

• Subjects who are participating in ongoing RCTs of therapeutic interventions (including CTIMPs)

• Plan to move out of the region in which the trial is being conducted within the next 2 years (proposed minimum follow-up period)