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Subclinical Hypothyroidism | The TRUST Study - Depression Substudy

Subclinical Hypothyroidism research study

What is the primary objective of this study?

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).

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Subclinical Hypothyroidism

Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:LevothyroxineThe intervention will start with Levothyroxine 50 µg daily (reduced to 25 µg in subjects <50Kg body weight or if known coronary heart disease - previous myocardial infarction or symptoms of angina pectoris) versus matching placebo; at 3 months if the serum TSH level is <0.4 mU/L dose will be reduced by 25 µg; TSH >=0.4 and <4.6 mU/L, no change to dose; TSH >=4.6mUL, additional 25 µg. The process will be repeated at 12 months then annually. Mock titration will be performed in the placebo group. The maximum possible dose of Levothyroxine that will be prescribed is 150μg (after 4 increments of 25μg at 3 months, 1, 2 and 3 years; from the starting dose of 50μg).

Drug:PlaceboControl patients will obtain a placebo pill of the same characteristics as the intervention drug, and mock titration will be carried out identically to the intervention drug. Pharmaceutical composition of placebo (100 mg): Lactose monohydrate 66 mg, Maize starch 25 mg, Gelatin 5 mg, Croscarmellose sodium 3.5 mg, Magnesium stearate (vegetable source) 0.5 mg.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Experimental: Drug: Levothyroxine The intervention will start with Levothyroxine 50 mcg daily (reduced to 25 mcg in subjects <50 kg of body weight or if known coronary heart disease - previous myocardial infarction or symptoms of angina pectoris) vs. matching placebo; at 3 months, if the serum TSH level is <0.4 mU/L, dose will be reduced by 25 mcg; TSH >=0.4 and <4.6 mU/L, no change to dose; TSH >=4.6 mU/L, additional 25 mcg. The process will be repeated at 12 months, then annually; mock titration will be performed in the placebo group. The maximum possible dose of Levothyroxine which will be prescribed is 150 mcg (after 4 increments of 25 mcg at 3 months, 1, 2, 3 years; from the starting dose of 50 mcg).

2Placebo Comparator: Drug: Placebo Control patients will obtain a placebo pill of the same characteristics as the intervention drug, and mock titration will be carried out identically to the intervention drug. Pharmaceutical composition of placebo (100 mg): Lactose monohydrate 66 mg, Maize starch 25 mg, Gelatin 5 mg, Croscarmellose sodium 3.5 mg, Magnesium stearate (vegetable source) 0.5 mg.

Study Status

Completed

Start Date: March 2013

Completed Date: April 5, 2018

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Change from baseline in 15-items Geriatric Depression Scale

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Nicolas Rodondi, MD, MAS

Lead Sponsor: University Hospital Inselspital, Berne

Collaborator: Leiden University Medical Center

More information:https://clinicaltrials.gov/show/NCT01853579

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