Expired Study
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Glen Oaks, New York 11004


Purpose:

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 summary:

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.


Criteria:

Inclusion Criteria: 1. Age 18-65; 2. DSM-IV diagnosis of BP I or BP II as per SCID; 3. Currently presenting with at least moderate levels of depression (HAM-D > 15; 4. 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; 5. Antidepressants and/or additional mood stabilizers are allowed, but dose should be stable for at least 2 weeks; Exclusion Criteria: 1. Evidence of acute mania or hypomania (as measured by CARS-M > 7); 2. Abnormal (outside of lab normal range) thyroid function tests; 3. Current thyroid hormone treatment; 4. 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); 5. EKG showing rhythm other than sinus or repolarization phase abnormalities; 6. Current alcohol or substance abuse or dependence in past month as per SCID; 7. Score of 3 or more on the suicide item of the HAM-D; 8. Females who are pregnant, breastfeeding, or of childbearing age and not using adequate birth control.


Study is Available At:


Original ID:

08-001


NCT ID:

NCT00790738


Secondary ID:


Study Acronym:

T3


Brief Title:

Liothyronine (T3) for Bipolar Depression


Official Title:

Randomized Double-Blind Trial of Liothyronine (T3) Augmentation to Treatment as Usual vs Placebo For The Treatment of Bipolar Depression


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

North Shore Long Island Jewish Health System


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

35


Enrollment Type:

Actual


Overall Contact Information

Official Name:Raphael J Braga, MD
Principal Investigator
The Zucker Hillside Hospital, North Shore - LIJHS

Study Dates

Start Date:July 2008
Completion Date:July 2012
Completion Type:Actual
Primary Completion Date:July 2012
Primary Completion Type:Actual
Verification Date:December 2012
Last Changed Date:December 17, 2012
First Received Date:November 10, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Clinical Global Impression scores
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Clinician-Administered Rating Scale for Mania
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Hamilton Rating Scale for Depression scores
Time Frame:8 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Liothyronine (T3)
Description:liothyronine (T3) up to 50 micrograms a day
Arm Name:1
Other Name:cytomel (liothyronine)
Intervention Type:Drug
Name:placebo
Description:placebo
Arm Name:2
Other Name:placebo

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:liothyronine (T3)
Study Arm Type:Placebo Comparator
Arm Name:2
Description:placebo

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:North Shore Long Island Jewish Health System
Agency Class:Other
Agency Type:Collaborator
Agency Name:National Alliance for Research on Schizophrenia and Depression

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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