Acceleration and Relapse Prevention With Triiodothyronine (T3) as an Adjunct to Electroconvulsive Therapy (ECT) (T3ECT)

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01299337
First received: June 10, 2008
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Depression
Drug: T3
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Acceleration and Relapse Prevention With Triiodothyronine (T3) as an Adjunct to Electroconvulsive Therapy (ECT)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Enrollment: 29
Study Start Date: June 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
placebo
Subjects will be randomized either receiving T3 or placebo.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299337

Locations
United States, Minnesota
Mayo Clinic Department of Psychiatry and Psychology
Rochester, Minnesota, United States, 55904
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Christopher L Sola, D.O. Mayo Clinic
  More Information

No publications provided

Responsible Party: Christopher Sola, D.O., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01299337     History of Changes
Other Study ID Numbers: 07-004759
Study First Received: June 10, 2008
Last Updated: May 10, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014