Status:
COMPLETED
The TRUST Study - Depression Substudy
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Leiden University Medical Center
University of Bern
Conditions:
Subclinical Hypothyroidism
Depression
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief 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 probl...
Detailed Description
Background Subclinical hypothyroidism is a common condition among older adults, particularly above the age of 65 years, with a prevalence reaching 10 to 15% of the population. This condition has been...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2018
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT01853579
Start Date
March 1 2013
End Date
April 5 2018
Last Update
June 14 2018
Active Locations (3)
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1
Leiden University Medical Center
Leiden, Netherlands, 2300
2
Department of General Internal Medicine
Lausanne, Canton of Vaud, Switzerland, 1011
3
University Clinic for General Internal Medicine, Bern University Hospital
Bern, Switzerland, 3010