Major Depressive DisorderNCT00421369
Augmentation of the Antidepressant Action of Sertraline With Triiodothyronine (T3)and Reboxetine: Clinical Efficacy, Adverse Effects and Predictors of Response.
A study testing sertraline, triiodothyronine (T3) and reboxetine in people with Major Depressive Disorder, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
In this project we aim to further refine indications for the use of the thyroid hormone - T3 for patients suffering from depression. We aim to identify a sub-group of patients who are more likely to respond to T3 and establish the time in the treatment course when T3 should be added. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- sertraline, triiodothyronine (T3) and reboxetine
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to Aug 2011
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Major Depressive Episode (MDE) in the context MDD according to DSM-IV criteria, without psychotic features.
- Hamilton Depression Scale (21 items, HAM-D) total >16 with item 1 (depressed mood) >2.
- Age 18-70 years.
- Male or female.
- Competent and willing to give written informed consent.
Who cannot join
- Clinical hyper- or hypothyroidism or any other thyroid illness.
- Neurological or other medical illness that may impact upon the study or limit prescription of the study medications.
- Significant suicidal risk [HAM-D item 3 (suicide) >2].
- Comorbidity with any Psychotic Disorder, Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Eating Disorder.
- Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.
- Treatment with the antidepressant, sertraline, in current episode.
Show all 9Show fewer
- More then one antidepressant trial or any augmentation treatment during current episode.
- Length of current episode >12 months
- Female subjects pregnant or lactating or not using adequate contraception.
Trial locations and contacts
1 site in 1 country.
About this study
In this project we aim to further refine indications for the use of the thyroid hormone - T3 for patients suffering from depression. We aim to identify a sub-group of patients who are more likely to respond to T3 and establish the time in the treatment course when T3 should be added. The results of this project could have significant, direct clinical implications.
Read the detailed description
The lifetime risk for major depressive disorder (MDD) is 15% in the general population. Current treatment approaches emphasize the achievement of remission. Remission implies virtual absence of depressive symptoms and is associated with better function and a better overall prognosis than response, which is usually defined as a 50% reduction in symptom severity. Sixty percent or more of patients treated optimally with antidepressants remain un-remitted and will need additional treatment. A potentially effective but under-exploited strategy to augment antidepressant effects is concurrent administration of the thyroid hormone, triiodothyronine (T3). We previously demonstrated the clinical efficacy and safety of T3 administered concurrently with the SSRI, sertraline, in the context of a randomized, double-blind placebo-controlled trial. Although all the patients were euthyroid, remission rates were significantly higher in the sertraline plus T3 group and were associated with significantly lower baseline T3 values and a significant decrease in serum thyroid stimulating hormone (TSH) values during the course of treatment.
The study aims to:
- Delineate a sub-population of depressed patients treated with sertraline, who are more likely to respond to T3 augmentation on the basis of thyroid function and genetic variation in thyroid pathway genes.
- Investigate the appropriate timing for the addition of T3.
- Assess the efficacy of reboxetine, a specific noradrenaline reuptake inhibitor, as a further supplement to the treatment of un-remitted patients. The results of this study could have a significant, direct clinical impact on the pharmacological treatment of MDD.
- Conditions
- Major Depressive Disorder
- Being tested
- sertraline, triiodothyronine (T3), reboxetine
- Keywords
- Major depressive disorder, Antidepressants, Triiodothyronine (T3), Thyroid Function, Augmentation, Thyroid pathway genes
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertralineDrug
triiodothyronine (T3)Drug
reboxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment outcome defined categorically as Remission: A Hamilton Depression Scale (HAM-D) less or equal to 6.
Secondary outcomes (3)
RESPONSE: Based on Hamilton Depression Scale (HAM-D)reduction of >50% from baseline to endpoint..
REMISSION: Based on the other rating scales applied in this project.
RESPONSE: Based on the other rating scales applied in this project.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startSep 2007
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Rena Cooper-Kazaz, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421369
- Sponsor's protocol ID
- t3rbx-HMO-CTIL
- Status last verified
- Jan 2007
- First submitted
- 11 Jan 2007
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of the Antidepressant Action of Sertraline With Triiodothyronine (T3)and Reboxetine: Clinical Efficacy, Adverse Effects and Predictors of Response.
- ClinicalTrials.gov ID
- NCT00421369
- Acronym / sponsor ID
- t3rbx-HMO-CTIL
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, Antidepressants, Triiodothyronine (T3), Thyroid Function, Augmentation, Thyroid pathway genes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2007
- Study completion
- Aug 2011 (actual)
- First posted
- 12 Jan 2007 (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.
In this project we aim to further refine indications for the use of the thyroid hormone - T3 for patients suffering from depression. We aim to identify a sub-group of patients who are more likely to respond to T3 and establish the time in the treatment course when T3 should be added. The results of this project could have significant, direct clinical implications.
Detailed description
The lifetime risk for major depressive disorder (MDD) is 15% in the general population. Current treatment approaches emphasize the achievement of remission. Remission implies virtual absence of depressive symptoms and is associated with better function and a better overall prognosis than response, which is usually defined as a 50% reduction in symptom severity. Sixty percent or more of patients treated optimally with antidepressants remain un-remitted and will need additional treatment. A potentially effective but under-exploited strategy to augment antidepressant effects is concurrent administration of the thyroid hormone, triiodothyronine (T3). We previously demonstrated the clinical efficacy and safety of T3 administered concurrently with the SSRI, sertraline, in the context of a randomized, double-blind placebo-controlled trial. Although all the patients were euthyroid, remission rates were significantly higher in the sertraline plus T3 group and were associated with significantly lower baseline T3 values and a significant decrease in serum thyroid stimulating hormone (TSH) values during the course of treatment.
The study aims to:
- Delineate a sub-population of depressed patients treated with sertraline, who are more likely to respond to T3 augmentation on the basis of thyroid function and genetic variation in thyroid pathway genes.
- Investigate the appropriate timing for the addition of T3.
- Assess the efficacy of reboxetine, a specific noradrenaline reuptake inhibitor, as a further supplement to the treatment of un-remitted patients. The results of this study could have a significant, direct clinical impact on the pharmacological treatment of MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Major Depressive Episode (MDE) in the context MDD according to DSM-IV criteria, without psychotic features.
- Hamilton Depression Scale (21 items, HAM-D) total >16 with item 1 (depressed mood) >2.
- Age 18-70 years.
- Male or female.
- Competent and willing to give written informed consent.
Key exclusion criteria (9 listed)
- Clinical hyper- or hypothyroidism or any other thyroid illness.
- Neurological or other medical illness that may impact upon the study or limit prescription of the study medications.
- Significant suicidal risk [HAM-D item 3 (suicide) >2].
- Comorbidity with any Psychotic Disorder, Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Eating Disorder.
- Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.
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 |
|---|---|---|
| sertraline | Drug | – |
| triiodothyronine (T3) | Drug | – |
| reboxetine | Drug | – |
Primary outcome
treatment outcome defined categorically as Remission: A Hamilton Depression Scale (HAM-D) less or equal to 6.
3 secondary outcomes
RESPONSE: Based on Hamilton Depression Scale (HAM-D)reduction of >50% from baseline to endpoint..
REMISSION: Based on the other rating scales applied in this project.
RESPONSE: Based on the other rating scales applied in this project.
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 22 Mar 2013.
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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.
Rena Cooper-Kazaz, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sertraline, triiodothyronine (T3) and reboxetine in people with Major Depressive Disorder, run by Hadassah Medical Organization at 1 site in Israel.
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 5 inclusion and 9 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 22 Mar 2013. 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 Israel. 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?
treatment outcome defined categorically as Remission: A Hamilton Depression Scale (HAM-D) less or equal to 6.. 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 22 Mar 2013.