Liothyronine (T3) for Bipolar Depression (T3)

• ClinicalTrials.gov Identifier: NCT00790738
• Recruitment Status: Completed
• First Posted: November 13, 2008
• Results First Posted: July 2, 2015
• Last Update Posted: July 2, 2015
• Sponsor: Northwell Health
• Collaborator: National Alliance for Research on Schizophrenia and Depression
• Information provided by (Responsible Party): Raphael Braga, Northwell Health

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Depression; Bipolar Disorder	Drug: Liothyronine (T3); Drug: placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Double-Blind Trial of Liothyronine (T3) Augmentation to Treatment as Usual vs Placebo For The Treatment of Bipolar Depression
• Study Start Date: July 2008
• Actual Primary Completion Date: July 2012
• Actual Study Completion Date: July 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; liothyronine (T3)	Drug: Liothyronine (T3); liothyronine (T3) up to 50 micrograms a day; Other Name: cytomel (liothyronine)
Placebo Comparator: 2; placebo	Drug: placebo; placebo

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New York

The Zucker Hillside Hospital

Glen Oaks, New York, United States, 11004

Sponsors and Collaborators

Northwell Health

National Alliance for Research on Schizophrenia and Depression

Investigators

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

More Information

• Responsible Party: Raphael Braga, MD, Northwell Health
• ClinicalTrials.gov Identifier: NCT00790738
• Other Study ID Numbers: 08-001
• First Posted: November 13, 2008
• Results First Posted: July 2, 2015
• Last Update Posted: July 2, 2015
• Last Verified: June 2015

Keywords provided by Raphael Braga, Northwell Health:

bipolar disorder; depression; treatment; randomized controlled trial

Additional relevant MeSH terms:

Depression; Depressive Disorder; Bipolar Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Bipolar and Related Disorders