Major DepressionPhase 3NCT00158990
Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression.
A Phase 3 study testing triiodothyronine and sertraline in people with Major Depression and Bipolar Disorder, run by Hadassah Medical Organization at 2 sites in 2 countries.
Trial summary
The purpose of this project is to determine whether concurrent treatment of patients with major depression (unipolar or bipolar) with triiodothyronine (T3) and sertraline, will lead to a stronger and/or more rapid antidepressant effect than treatment with sertraline alone. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depression, Bipolar Disorder, Unipolar Depression
- What is being tested?
- triiodothyronine and sertraline
- How many people
- 220 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2002to Jul 2007
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Major Depressive Episode (MDE) in the context of Bipolar Disorder I or II (BPD-I or BPD-II) or Major Depressive Disorder (UPD), according to DSM-IV criteria, without psychotic features.
- Hamilton Depression Scale (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
- No clinical hyper- or hypothyroidism nor other thyroid illness.
- No neurological or other physical illness that may impact upon the study or limit prescription of the study medications.
- No lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.
- No significant suicidal risk (HAM-D item 3 (suicide) <3).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Global Medical Institutes
Princeton, New Jersey, 08540
About this study
Official title: Triiodothyronine (T3) Supplementation in Bipolar and Unipolar Depression: A Random Assignment, Double Blind, Placebo-Controlled Study.
The purpose of this project is to determine whether concurrent treatment of patients with major depression (unipolar or bipolar) with triiodothyronine (T3) and sertraline, will lead to a stronger and/or more rapid antidepressant effect than treatment with sertraline alone.
Read the detailed description
AIM: To determine the therapeutic efficacy and adverse effects of triiodothyronine (T3) as a supplement to the treatment of bipolar depression (BPD) with a mood stabilizer (MS) (lithium - Li, valproic acid - VPA or carbamazepine - CBZ) and the specific serotonin reuptake inhibitor (SSRI), sertraline; and as a supplement to the treatment of unipolar depression (UPD) with sertraline.
METHOD: A random assignment, double blind, placebo-controlled trial separately evaluating patients with a) BPD who are treated with MS + sertraline + T3 or MS + sertraline + placebo and b) UPD who are treated with sertraline + T3 or sertraline + placebo, for up to 8 weeks in both cases. The design of the trial will permit both the outcome of treatment and the speed of response to be evaluated.
- Conditions
- Major Depression, Bipolar Disorder, Unipolar Depression
- Being tested
- triiodothyronine, sertraline
- Keywords
- major depression, bipolar disorder, unipolar depression, sertraline, triiodothyronine
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triiodothyronineDrug
sertralineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response - HAM-D-21 improvement >50% at 8 weeks
Remission - final HAM-D-21 total <7 at 8 weeks
Secondary outcomes (1)
Rate of change in HAM-D-21 scores over 8 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 2002
- Study completionJul 2007
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Investigators
- Bernard Lerer, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158990
- Sponsor's protocol ID
- BPL-0100-HMO-CTIL
- Status last verified
- Aug 2005
- First submitted
- 8 Sep 2005
- Last updated
- 4 Jan 2007
- Results posted
- No
Publications
Cooper-Kazaz R, Apter JT, Cohen R, Karagichev L, Muhammed-Moussa S, Grupper D, Drori T, Newman ME, Sackeim HA, Glaser B, Lerer B. Combined treatment with sertraline and liothyronine in major depression: a randomized, double-blind, placebo-controlled trial. Arch Gen Psychiatry. 2007 Jun;64(6):679-88. doi: 10.1001/archpsyc.64.6.679.
PubMed 17548749
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triiodothyronine (T3) Supplementation in Bipolar and Unipolar Depression: A Random Assignment, Double Blind, Placebo-Controlled Study.
- ClinicalTrials.gov ID
- NCT00158990
- Acronym / sponsor ID
- BPL-0100-HMO-CTIL
- Conditions
- Major Depression, Bipolar Disorder, Unipolar Depression
- Keywords
- major depression, bipolar disorder, unipolar depression, sertraline, triiodothyronine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Oct 2002
- Study completion
- Jul 2007
- First posted
- 12 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.
The purpose of this project is to determine whether concurrent treatment of patients with major depression (unipolar or bipolar) with triiodothyronine (T3) and sertraline, will lead to a stronger and/or more rapid antidepressant effect than treatment with sertraline alone.
Detailed description
AIM: To determine the therapeutic efficacy and adverse effects of triiodothyronine (T3) as a supplement to the treatment of bipolar depression (BPD) with a mood stabilizer (MS) (lithium - Li, valproic acid - VPA or carbamazepine - CBZ) and the specific serotonin reuptake inhibitor (SSRI), sertraline; and as a supplement to the treatment of unipolar depression (UPD) with sertraline.
METHOD: A random assignment, double blind, placebo-controlled trial separately evaluating patients with a) BPD who are treated with MS + sertraline + T3 or MS + sertraline + placebo and b) UPD who are treated with sertraline + T3 or sertraline + placebo, for up to 8 weeks in both cases. The design of the trial will permit both the outcome of treatment and the speed of response to be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Major Depressive Episode (MDE) in the context of Bipolar Disorder I or II (BPD-I or BPD-II) or Major Depressive Disorder (UPD), according to DSM-IV criteria, without psychotic features.
- Hamilton Depression Scale (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 (4 listed)
- No clinical hyper- or hypothyroidism nor other thyroid illness.
- No neurological or other physical illness that may impact upon the study or limit prescription of the study medications.
- No lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.
- No significant suicidal risk (HAM-D item 3 (suicide) <3).
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 |
|---|---|---|
| triiodothyronine | Drug | – |
| sertraline | Drug | – |
Primary outcome
Response - HAM-D-21 improvement >50% at 8 weeks
Remission - final HAM-D-21 total <7 at 8 weeks
1 secondary outcome
Rate of change in HAM-D-21 scores over 8 week treatment period
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 4 Jan 2007.
- Derived from this study: PubMed 17548749Cooper-Kazaz R, Apter JT, Cohen R, Karagichev L, Muhammed-Moussa S, Grupper D, Drori T, Newman ME, Sackeim HA, Glaser B, Lerer B. Combined treatment with sertraline and liothyronine in major depression: a randomized, double-blind, placebo-controlled trial. Arch Gen Psychiatry. 2007 Jun;64(6):679-88. doi: 10.1001/archpsyc.64.6.679.
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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.
Bernard Lerer, MD principal investigator
Hadassah Medical Organization
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing triiodothyronine and sertraline in people with Major Depression and Bipolar Disorder, run by Hadassah Medical Organization at 2 sites in 2 countries.
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 4 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 4 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Response - HAM-D-21 improvement >50% at 8 weeks. The study lists 2 primary outcomes in all. 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 NCT00158990, 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 4 Jan 2007.