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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
Sponsor:
Information provided by:
Mayo Clinic

Tracking Information
First Submitted Date June 10, 2008
First Posted Date February 18, 2011
Last Update Posted Date May 11, 2012
Study Start Date June 2008
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 16, 2011)
To determine if people get better faster and stay better longer using T3 as adjunct to ECT. [ Time Frame: Phase A and Phase B ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01299337 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acceleration and Relapse Prevention With Triiodothyronine (T3) as an Adjunct to Electroconvulsive Therapy (ECT)
Official Title Acceleration and Relapse Prevention With Triiodothyronine (T3) as an Adjunct to Electroconvulsive Therapy (ECT)
Brief Summary

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).
Detailed Description

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.

Hypotheses:

  1. 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)].
  2. 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.
  3. 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.
  4. 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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
Sampling Method Probability Sample
Study Population

Consultants at the Department of Psychiatry and Psychology will evaluate patients with a diagnosis of depression (unipolar) for ECT. When a patient matches the study's diagnostic criteria, and does not meet any of the exclusion criteria, he/she will be asked to participate in the study.

Patient will be contacted prior to first ECT Treatment by study personnel

Condition Depression
Intervention Drug: T3
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
Study Groups/Cohorts placebo
Subjects will be randomized either receiving T3 or placebo.
Intervention: Drug: T3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 10, 2012)
29
Original Estimated Enrollment
 (submitted: February 16, 2011)
134
Actual Study Completion Date April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Ages 18-64, male and female, any race/ethnicity
  • Current diagnosis of major depression (unipolar)
  • Currently Hospitalized at Mayo Clinic Physician recommendation for ECT treatment at Mayo Clinic
  • Willing to return to Mayo Clinic for follow-up

Exclusion Criteria:

  • Inability to speak English
  • Inability or unwillingness to provide written informed consent
  • Psychotic depression (SCID-confirmed)
  • Court-ordered involuntary ECT
  • Currently receiving maintenance ECT
  • Unstable current medical condition
  • A condition that would deem triiodothyronine treatment unsafe
  • Diagnosis of primary thyroid disorder
  • Lithium treatment within 6 weeks of randomization
  • Currently taking levothyroxine (Synthroid®) or triiodothyronine (Cytomel®)
  • Subclinical hypo- or hyperthyroidism
  • History of atrial fibrillation or any cardiac arrhythmia except sinus bradycardia
  • History of myocardial infarction within the past 12 months or unstable coronary artery disease
  • Pregnancy
  • History of Osteoporosis
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01299337
Other Study ID Numbers 07-004759
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Christopher Sola, D.O., Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Christopher L Sola, D.O. Mayo Clinic
PRS Account Mayo Clinic
Verification Date May 2012