Acceleration and Relapse Prevention With Triiodothyronine (T3) as an Adjunct to Electroconvulsive Therapy (ECT) (T3ECT)
The purpose of this study is:
- To evaluate liothyronine (Cytomel) as an accelerating agent (i.e. faster rate to clinical remission) to electroconvulsive therapy.
- To evaluate whether thyroid supplement acceleration can reduce the neurocognitive side effect of ECT treatment.
- To evaluate whether thyroid status at the time of remission is associated with subsequent relapse rate.
- To evaluate genetic polymorphisms in enzymes responsible for thyroid metabolism and the serotonin transporter promoter gene in depression (5-HTTLRP).
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Acceleration and Relapse Prevention With Triiodothyronine (T3) as an Adjunct to Electroconvulsive Therapy (ECT)|
- To determine if people get better faster and stay better longer using T3 as adjunct to ECT. [ Time Frame: Phase A and Phase B ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Thyroid measures at time of sustained response will include free T3, free T4, and TSH. All draws will be done before ECT treatment. An additional free T3 will be obtained at the second visit that confirms sustained response. The mean free T3 will be used as the outcome measure. If a suppressed TSH is found, a TSH be repeated 1 week later. At the beginning of the study 30 mL of blood will be drawn and a portion of the collected blood sample will undergo DNA extraction. The extracted DNA will undergo genetic analysis. The remainder owill be immortalized and stored for future study. Blood will be drawn into 1 10-mL EDTA tube and 2 10-mL Heparin tubes . Samples will be stored at Mayo Clinic BAP Lab for subsequent DNA extraction, analysis, and storage.
|Study Start Date:||June 2008|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Subjects will be randomized either receiving T3 or placebo.
Given each day of ECT treatment 25 mg for the first 5 days increasing to 50 mg for the duration of treatment.
Other Name: triiodythronine
This is a single-site, randomized, placebo-controlled trial of concurrent triiodothyronine (Cytomel® 25-50 mcg/d) to electroconvulsive therapy (ECT) in patients with a major depressive episode referred to ECT. Goals of this application are to: 1) evaluate whether thyroid status at time of sustained clinical response is associated with subsequent relapse rate, 2) evaluate triiodothyronine (Cytomel®) as an accelerating agent (i.e. faster rate to sustained clinical response) to electroconvulsive ECT treatment, and 3) evaluate whether thyroid acceleration can reduce the neurocognitive side effects of ECT. 4) To evaluate genetic polymorphisms in enzymes responsible for thyroid metabolism and the serotonin transporter promoter gene in depression (5-HTTLRP).
The primary outcome measure for this study, time to relapse, is defined as a Hamilton Depression Score (HAMD-24) ≥16 and an increase of ≥10 points from sustained response baseline. Secondary outcomes measures are time to sustained response, defined as a ≥60% reduction in the HAMD-24 score, and neurocognitive side effect burden as rated by the modified Mini Mental Status Examination at time of sustained clinical response.
- Within a 6-month study period, mean serum free T3 at time of sustained clinical response will correlate with time to subsequent relapse [defined as a HAMD-24 score ≥16 with an increase of ≥10 points from baseline (sustained response)].
- In comparison to placebo, triiodothyronine (Cytomel®, 25-50 mcg) will accelerate time to sustained clinical response [defined as a ≥60% reduction in the Hamilton Rating Scale for Depression, 24-item, (HAMD-24) score and a HAMD-24 total score ≤10 for 2 consecutive visits] in depressed patients referred to ECT.
- In comparison to placebo, at time of sustained clinical response, there will be less ECT-related neurocognitive side effects, as rated by the modified Mini-Mental Status Examination (mMMSE), associated with triiodothyronine.
a. The 5-HTTLPR long allele (l) and (l)/(l) genotype will be associated with a faster treatment response.
b. The DI-C785T allele will be associated with lower T3 levels at baseline and faster treatment response.
|United States, Minnesota|
|Mayo Clinic Department of Psychiatry and Psychology|
|Rochester, Minnesota, United States, 55904|
|Principal Investigator:||Christopher L Sola, D.O.||Mayo Clinic|