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Liothyronine (T3) for Bipolar Depression (T3)

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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:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Raphael Braga, Northwell Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Depression
Bipolar Disorder
Interventions Drug: Liothyronine (T3)
Drug: placebo
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Liothyronine (T3) Placebo
Hide Arm/Group Description

liothyronine (T3)

Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day.

placebo

placebo: placebo

Period Title: Overall Study
Started 5 6
Completed 3 3
Not Completed 2 3
Arm/Group Title Liothyronine (T3) Placebo Total
Hide Arm/Group Description

liothyronine (T3)

Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day

placebo

placebo: placebo

Total of all reporting groups
Overall Number of Baseline Participants 5 6 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 6 participants 11 participants
43.8  (9.5) 46.4  (5.9) 45.2  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
Female
4
  80.0%
1
  16.7%
5
  45.5%
Male
1
  20.0%
5
  83.3%
6
  54.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 6 participants 11 participants
5 6 11
1.Primary Outcome
Title Hamilton Rating Scale for Depression Scores
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine (T3) Placebo
Hide Arm/Group Description:

liothyronine (T3)

Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day.

placebo

placebo: placebo

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.50  (3.54) 7.25  (5.44)
2.Secondary Outcome
Title Clinician-Administered Rating Scale for Mania
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine (T3) Placebo
Hide Arm/Group Description:

liothyronine (T3)

Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day.

placebo

placebo: placebo

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.5  (0.71) 2  (1.82)
3.Secondary Outcome
Title Clinical Global Impression Scores
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine (T3) Placebo
Hide Arm/Group Description:

liothyronine (T3)

Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day.

placebo

placebo: placebo

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
4  (0) 3  (0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liothyronine (T3) Placebo
Hide Arm/Group Description

liothyronine (T3)

Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day

placebo

placebo: placebo

All-Cause Mortality
Liothyronine (T3) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Liothyronine (T3) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      1/6 (16.67%)    
Cardiac disorders     
Palpitation  0/5 (0.00%)  0 1/6 (16.67%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Liothyronine (T3) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/5 (80.00%)      4/6 (66.67%)    
Cardiac disorders     
Tachycardia   1/5 (20.00%)  1 0/6 (0.00%)  0
General disorders     
Malaise   0/5 (0.00%)  0 1/6 (16.67%)  1
Metabolism and nutrition disorders     
Increased Appetite   3/5 (60.00%)  3 0/6 (0.00%)  0
Nervous system disorders     
excitment  0/5 (0.00%)  0 2/6 (33.33%)  2
Tremor   0/5 (0.00%)  0 1/6 (16.67%)  1
Tinnitus   0/5 (0.00%)  0 1/6 (16.67%)  1
Headache   0/5 (0.00%)  0 2/6 (33.33%)  2
Psychiatric disorders     
Insomnia   3/5 (60.00%)  3 1/6 (16.67%)  1
Hypersomnia   1/5 (20.00%)  1 1/6 (16.67%)  1
Drowsiness   0/5 (0.00%)  0 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
Despite several changes made in order to enhance recruitment during the study period, the study was markedly underpowered. Therefore, no definitive conclusions could be drawn from the data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Raphael J. Braga, MD
Organization: The Zucker Hillside Hospital
Phone: 718-4708060
Responsible Party: Raphael Braga, Northwell Health
ClinicalTrials.gov Identifier: NCT00790738     History of Changes
Other Study ID Numbers: 08-001
First Submitted: November 10, 2008
First Posted: November 13, 2008
Results First Submitted: May 21, 2015
Results First Posted: July 2, 2015
Last Update Posted: July 2, 2015