DepressionT3ECTNCT01299337
Acceleration and Relapse Prevention With Triiodothyronine (T3) as an Adjunct to Electroconvulsive Therapy (ECT)
An observational study of Depression, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depression
- What is being tested?
- T3
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Department of Psychiatry and Psychology
Rochester, Minnesota, 55904
About this study
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).
Read the 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:
- 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.
- The DI-C785T allele will be associated with lower T3 levels at baseline and faster treatment response.
- Conditions
- Depression
- Being tested
- T3
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T3Drug
Also called triiodythronine
Given each day of ECT treatment 25 mg for the first 5 days increasing to 50 mg for the duration of treatment.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Subjects will be randomized either receiving T3 or placebo. Receives: Drug: T3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if people get better faster and stay better longer using T3 as adjunct to ECT.
Measured: Phase A and Phase B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startJun 2008
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Christopher L Sola, D.O., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299337
- Sponsor's protocol ID
- 07-004759
- Acronym
- T3ECT
- Status last verified
- May 2012
- First submitted
- 10 Jun 2008
- Last updated
- 11 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceleration and Relapse Prevention With Triiodothyronine (T3) as an Adjunct to Electroconvulsive Therapy (ECT)
- ClinicalTrials.gov ID
- NCT01299337
- Acronym / sponsor ID
- T3ECT / 07-004759
- Conditions
- Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- The DI-C785T allele will be associated with lower T3 levels at baseline and faster treatment response.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| placebo | – | Drug: T3Subjects will be randomized either receiving T3 or placebo. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- Inability to speak English
- Inability or unwillingness to provide written informed consent
- Psychotic depression (SCID-confirmed)
- Court-ordered involuntary ECT
- Currently receiving maintenance ECT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T3Also: triiodythronineGiven each day of ECT treatment 25 mg for the first 5 days increasing to 50 mg for the duration of treatment. | Drug | placebo |
Primary outcome
To determine if people get better faster and stay better longer using T3 as adjunct to ECT.
Time frame: Phase A and Phase B
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher L Sola, D.O. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if people get better faster and stay better longer using T3 as adjunct to ECT. (time frame: Phase A and Phase B). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2012.