Acceleration and Relapse Prevention With Triiodothyronine (T3) as an Adjunct to Electroconvulsive Therapy (ECT) (T3ECT)
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|ClinicalTrials.gov Identifier: NCT01299337|
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : May 11, 2012
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).
|Condition or disease||Intervention/treatment|
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.
|Study Type :||Observational|
|Actual Enrollment :||29 participants|
|Official Title:||Acceleration and Relapse Prevention With Triiodothyronine (T3) as an Adjunct to Electroconvulsive Therapy (ECT)|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
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
- To determine if people get better faster and stay better longer using T3 as adjunct to ECT. [ Time Frame: Phase A and Phase B ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299337
|United States, Minnesota|
|Mayo Clinic Department of Psychiatry and Psychology|
|Rochester, Minnesota, United States, 55904|
|Principal Investigator:||Christopher L Sola, D.O.||Mayo Clinic|