Liothyronine (T3) for Bipolar Depression - Full Text View

Sponsors and Collaborators:	North Shore Long Island Jewish Health System National Alliance for Research on Schizophrenia and Depression
Information provided by:	North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00790738

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.

Condition	Intervention	Phase
Depression Bipolar Disorder	Drug: Liothyronine (T3) Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Double-Blind Trial of Liothyronine (T3) Augmentation to Treatment as Usual vs Placebo For The Treatment of Bipolar Depression

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Liothyronine sodium Triiodothyronine

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:

Hamilton Rating Scale for Depression scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinician-Administered Rating Scale for Mania [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental liothyronine (T3)	Drug: Liothyronine (T3) liothyronine (T3) up to 50 micrograms a day
2: Placebo Comparator placebo	Drug: placebo placebo

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790738

Contacts

Contact: Anu Tyagi	(718) 470- 8146	atyagi@nshs.edu
Contact: Raphael J Braga, MD	(718) 470-4801	rbraga@nshs.edu

Locations

United States, New York
The Zucker Hillside Hospital	Recruiting
Glen Oaks, New York, United States, 11004
Contact: Anu Tyagi 718-470-8146
Principal Investigator: Raphael J Braga, MD

Sponsors and Collaborators

North Shore Long Island Jewish Health System

National Alliance for Research on Schizophrenia and Depression

Investigators

Principal Investigator:

Raphael J Braga, MD

The Zucker Hillside Hospital, North Shore - LIJHS

More Information

No publications provided

Responsible Party:	The Zucker Hillside Hospital - North Shore LIJ Health System ( Raphael J Braga, MD )
Study ID Numbers:	08-001
Study First Received:	November 10, 2008
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00790738 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:

bipolar disorder
depression
treatment
randomized controlled trial

Study placed in the following topic categories:

Affective Disorders, Psychotic
Depression
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Affective Disorders, Psychotic
Depression
Mental Disorders
Bipolar Disorder

Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 10, 2009