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

NCT01299337 | Completed DMC

• 1 other identifier: 07-004759
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• To determine if people get better faster and stay better longer using T3 as adjunct to ECT.

  Phase A and Phase B

Study Arms (1)

placebo

Subjects will be randomized either receiving T3 or placebo.

Drug: T3

Interventions

T3 DRUG

Given each day of ECT treatment 25 mg for the first 5 days increasing to 50 mg for the duration of treatment.

Also known as: triiodythronine

placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Department of Psychiatry and Psychology

Rochester, Minnesota, 55904, United States

Location

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.

MeSH Terms

Conditions

Depression

Interventions

Triiodothyronine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thyronines; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroxine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Christopher L Sola, D.O.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: February 18, 2011
• Study Start: June 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 11, 2012

Record last verified: 2012-05

Locations

US (1)