Major DepressionPhase 4NCT00208702
Thyroid Medication and Antidepressants for Treating Major Depression
A Phase 4 study testing Triiodothyronine and Sertraline in people with Major Depression, run by Emory University at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of treatment with supplemental triiodothyronine (T3, Cytomel) and sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI), in improving symptoms of major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Triiodothyronine and Sertraline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1996to Jul 2003
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female between the ages of 18 and 60. (The upper age is limited to 60 because thyroid changes, including blunting of the TSH response to TRH occurs with age and can potentially confound the relationship between the HPT axis and MDD.)
- Primary diagnosis of unipolar Major Depressive Disorder
- HAM-D (21 item) score >18
Who cannot join
- Alcohol abuse or alcohol dependence within the past year.
- Psychoactive substance abuse or dependence within the past year.
- Clinical evidence of severe Personality Disorder that would make study participation and completion unlikely.
- ECT within the past 6 months.
- Grade I hypothyroidism defined as low thyroid hormone levels with an associated elevated TSH; hyperthyroidism defined as elevated thyroid hormone concentrations with a low TSH.
- Serious and unstable medical illnesses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thyroid Axis in Major Depression
This study will evaluate the effectiveness of treatment with supplemental triiodothyronine (T3, Cytomel) and sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI), in improving symptoms of major depressive disorder (MDD).
Read the detailed description
The primary hypothesis is that triiodothyronine (Cytomel) supplementation of the antidepressant sertraline (Zoloft) will result in a greater improvement in HAM-D scores compared to placebo in the treatment of Major Depressive Disorder (MDD).
The goals of this proposal are to examine the relationship between Major Depressive Disorder (MDD) and abnormalities of the hypothalamic pituitary thyroid (HPT) axis. This protocol will systematically examine the value of supplemental triiodothyronine (T3, Cytomel) with sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI) in the treatment of MDD. The focus will be on two overlapping populations: 1) those with evidence of HPT abnormalities, and 2) those who did not respond to a previous adequate SSRI trial
- Conditions
- Major Depression
- Being tested
- Triiodothyronine, Placebo, Sertraline
- Keywords
- Major Depressive Disorder, Mental Health, Depression
- Medical subject headings
- Depressive Disorder, Major, Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriiodothyronineDrug
Also called Cytomel
PlaceboOther
SertralineDrug
Also called Zoloft
| Study group | Role | What they receive |
|---|---|---|
| sertraline + triiodothyronine | Experimental | Not described Receives: Drug: Triiodothyronine; Drug: Sertraline |
| sertraline + placebo | Placebo comparator | Not described Receives: Other: Placebo; Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS score
Secondary outcomes (1)
CGI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 1996
- Primary completionJul 2003
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Boadie W. Dunlop, Emory University
- Investigators
- Boadie W Dunlop, MD, MS, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208702
- Sponsor's protocol ID
- 0431-1996
- Other IDs
- R01MH056946, 431-1996, DSIR AT-SO
- Status last verified
- Nov 2015
- First submitted
- 13 Sep 2005
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Garlow SJ, Dunlop BW, Ninan PT, Nemeroff CB. The combination of triiodothyronine (T3) and sertraline is not superior to sertraline monotherapy in the treatment of major depressive disorder. J Psychiatr Res. 2012 Nov;46(11):1406-13. doi: 10.1016/j.jpsychires.2012.08.009. Epub 2012 Sep 7.
PubMed 22964160
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Axis in Major Depression
- ClinicalTrials.gov ID
- NCT00208702
- Acronym / sponsor ID
- 0431-1996
- Conditions
- Major Depression
- Keywords
- Major Depressive Disorder, Mental Health, Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 1996
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jul 2003 (actual)
- First posted
- 21 Sep 2005 (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.
This study will evaluate the effectiveness of treatment with supplemental triiodothyronine (T3, Cytomel) and sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI), in improving symptoms of major depressive disorder (MDD).
Detailed description
The primary hypothesis is that triiodothyronine (Cytomel) supplementation of the antidepressant sertraline (Zoloft) will result in a greater improvement in HAM-D scores compared to placebo in the treatment of Major Depressive Disorder (MDD).
The goals of this proposal are to examine the relationship between Major Depressive Disorder (MDD) and abnormalities of the hypothalamic pituitary thyroid (HPT) axis. This protocol will systematically examine the value of supplemental triiodothyronine (T3, Cytomel) with sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI) in the treatment of MDD. The focus will be on two overlapping populations: 1) those with evidence of HPT abnormalities, and 2) those who did not respond to a previous adequate SSRI trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sertraline + triiodothyronine | Experimental | Drug: Triiodothyronine, Drug: Sertraline |
| sertraline + placebo | Placebo comparator | Other: Placebo, Drug: Sertraline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female between the ages of 18 and 60. (The upper age is limited to 60 because thyroid changes, including blunting of the TSH response to TRH occurs with age and can potentially confound the relationship between the HPT axis and MDD.)
- Primary diagnosis of unipolar Major Depressive Disorder
- HAM-D (21 item) score >18
Key exclusion criteria (6 listed)
- Alcohol abuse or alcohol dependence within the past year.
- Psychoactive substance abuse or dependence within the past year.
- Clinical evidence of severe Personality Disorder that would make study participation and completion unlikely.
- ECT within the past 6 months.
- Grade I hypothyroidism defined as low thyroid hormone levels with an associated elevated TSH; hyperthyroidism defined as elevated thyroid hormone concentrations with a low TSH.
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 |
|---|---|---|
| TriiodothyronineAlso: Cytomel | Drug | sertraline + triiodothyronine |
| Placebo | Other | sertraline + placebo |
| SertralineAlso: Zoloft | Drug | sertraline + placebo, sertraline + triiodothyronine |
Primary outcome
MADRS score
1 secondary outcome
CGI
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 17 Nov 2015.
- Results publication: PubMed 22964160Garlow SJ, Dunlop BW, Ninan PT, Nemeroff CB. The combination of triiodothyronine (T3) and sertraline is not superior to sertraline monotherapy in the treatment of major depressive disorder. J Psychiatr Res. 2012 Nov;46(11):1406-13. doi: 10.1016/j.jpsychires.2012.08.009. Epub 2012 Sep 7.
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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.
Boadie W Dunlop, MD, MS principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triiodothyronine and Sertraline in people with Major Depression, run by Emory University 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 3 inclusion and 6 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 17 Nov 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
MADRS score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00208702, which also lists 1 linked publication.
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 17 Nov 2015.