- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00790738
Liothyronine (T3) for Bipolar Depression (T3)
June 5, 2015 updated by: Raphael Braga, Northwell Health
Randomized Double-Blind Trial of Liothyronine (T3) Augmentation to Treatment as Usual vs Placebo For The Treatment of Bipolar Depression
This study evaluates the efficacy of the thyroid hormone T3 for depression in patients with bipolar disorder.
In this study patients will be randomized to receive T3 or placebo.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Bipolar affective disorder is a debilitating illness, and is characterized by depression episodes that dominates the longitudinal course and are most difficult to treat.
Controlled trials with monotherapy mood stabilizers such as lithium and valproate show little to no efficacy and antidepressants may offer no additional efficacy.
Recently there has been a growing interest in the use of quetiapine in bipolar depression.
However, a successful treatment may take up to 8 weeks, and full remission is achieved in only 50% of patients.
Thyroid hormone augmentation strategies have been used in unipolar depression with good results, but there is a paucity of its efficacy in bipolar depression (BD).
To our knowledge there are no controlled studies regarding the efficacy of thyroid augmentation in BD.
The present study proposes to evaluate the efficacy of T3 as an augmentation to treatment as usual in the treatment of BD.
We plan to enroll patients with bipolar disorder I or II who are currently presenting with depressive symptoms.
Patients will be randomized to 2 groups - liothyronine or placebo Results will provide information on the possible role of thyroid hormone augmentation in the treatment of patients with bipolar depression, and may contribute to alleviate the burden of this disabling condition.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Glen Oaks, New York, United States, 11004
- The Zucker Hillside Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18-65;
- DSM-IV diagnosis of BP I or BP II as per SCID;
- Currently presenting with at least moderate levels of depression (HAM-D > 15;
- Patient has to be on stable dose of at least one mood stabilizer (lithium, valproate, carbamazepine, lamotrigine, second generation antipsychotics) for at least 4 weeks as per history;
- Antidepressants and/or additional mood stabilizers are allowed, but dose should be stable for at least 2 weeks;
Exclusion Criteria:
- Evidence of acute mania or hypomania (as measured by CARS-M > 7);
- Abnormal (outside of lab normal range) thyroid function tests;
- Current thyroid hormone treatment;
- Any medical condition considered a contraindication for treatment with T3 (i.e. history of myocardial infarction, cardiac arrhythmia, severe cardiac insufficiency, Autoimmune Thyroid Disease /Hashimoto's Thyroiditis as determined by anti-thyroid antibody testing, previous or current thyroid adenoma, hyperthyroidism);
- EKG showing rhythm other than sinus or repolarization phase abnormalities;
- Current alcohol or substance abuse or dependence in past month as per SCID;
- Score of 3 or more on the suicide item of the HAM-D;
- Females who are pregnant, breastfeeding, or of childbearing age and not using adequate birth control.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
placebo
|
placebo
|
Experimental: 1
liothyronine (T3)
|
liothyronine (T3) up to 50 micrograms a day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamilton Rating Scale for Depression Scores
Time Frame: 8 weeks
|
The Hamilton Rating Scale for Depression (HRSD) is a checklist of items ranked from 0-4 or 0-2, that was designed to measure the severity of depressive symptoms.
The scale ranges from 0 to 50, and the following thresholds are used: very severe >23, severe 19-22, moderate 14-18, mild 8-13 and normal ≤7.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician-Administered Rating Scale for Mania
Time Frame: 8 weeks
|
The Clinician-Administered Rating Scale for Mania (CARS-M) contains 15 items rated from 0-5 or 0-6 on a Likert scale.
It was developed to assess severity of manic symtoms.
The scale ranges from 0 to 50, and the following thresholds are used: severe ≥26, moderate 16-25, mild 8-15 and normal ≤7.
|
8 weeks
|
Clinical Global Impression Scores
Time Frame: 8 weeks
|
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
At the time of rating patients are rated as: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Raphael J Braga, MD, The Zucker Hillside Hospital, North Shore - LIJHS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
November 10, 2008
First Submitted That Met QC Criteria
November 12, 2008
First Posted (Estimate)
November 13, 2008
Study Record Updates
Last Update Posted (Estimate)
July 2, 2015
Last Update Submitted That Met QC Criteria
June 5, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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