search
Back to results

Liothyronine (T3) for Bipolar Depression (T3)

Primary Purpose

Depression, Bipolar Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Liothyronine (T3)
placebo
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring bipolar disorder, depression, treatment, randomized controlled trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Zucker Hillside Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

liothyronine (T3)

placebo

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression Scores
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

Clinician-Administered Rating Scale for Mania
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.
Clinical Global Impression Scores
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.

Full Information

First Posted
November 10, 2008
Last Updated
June 5, 2015
Sponsor
Northwell Health
Collaborators
National Alliance for Research on Schizophrenia and Depression
search

1. Study Identification

Unique Protocol Identification Number
NCT00790738
Brief Title
Liothyronine (T3) for Bipolar Depression
Acronym
T3
Official Title
Randomized Double-Blind Trial of Liothyronine (T3) Augmentation to Treatment as Usual vs Placebo For The Treatment of Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Bipolar Disorder
Keywords
bipolar disorder, depression, treatment, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
liothyronine (T3)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Liothyronine (T3)
Other Intervention Name(s)
cytomel (liothyronine)
Intervention Description
liothyronine (T3) up to 50 micrograms a day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression Scores
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Clinician-Administered Rating Scale for Mania
Description
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.
Time Frame
8 weeks
Title
Clinical Global Impression Scores
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael J Braga, MD
Organizational Affiliation
The Zucker Hillside Hospital, North Shore - LIJHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Liothyronine (T3) for Bipolar Depression

We'll reach out to this number within 24 hrs