Trial Outcomes & Findings for Liothyronine (T3) for Bipolar Depression (NCT NCT00790738)

Last Updated: 2015-07-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

11 participants

Primary outcome timeframe

8 weeks

Results posted on

2015-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Liothyronine (T3) liothyronine (T3) Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day.	Placebo placebo placebo: placebo
Overall Study STARTED	5	6
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Liothyronine (T3) for Bipolar Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liothyronine (T3) n=5 Participants liothyronine (T3) Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day	Placebo n=6 Participants placebo placebo: placebo	Total n=11 Participants Total of all reporting groups
Age, Continuous	43.8 years STANDARD_DEVIATION 9.5 • n=5 Participants	46.4 years STANDARD_DEVIATION 5.9 • n=7 Participants	45.2 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Liothyronine (T3) n=5 Participants liothyronine (T3) Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day.	Placebo n=6 Participants placebo placebo: placebo
Hamilton Rating Scale for Depression Scores	3.50 units on a scale Standard Deviation 3.54	7.25 units on a scale Standard Deviation 5.44

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Liothyronine (T3) n=5 Participants liothyronine (T3) Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day.	Placebo n=6 Participants placebo placebo: placebo
Clinician-Administered Rating Scale for Mania	0.5 units on a scale Standard Deviation 0.71	2 units on a scale Standard Deviation 1.82

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Liothyronine (T3) n=5 Participants liothyronine (T3) Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day.	Placebo n=6 Participants placebo placebo: placebo
Clinical Global Impression Scores	4 units on a scale Standard Deviation 0	3 units on a scale Standard Deviation 0

Adverse Events

Liothyronine (T3)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Liothyronine (T3) n=5 participants at risk liothyronine (T3) Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day	Placebo n=6 participants at risk placebo placebo: placebo
Cardiac disorders Palpitation	0.00% 0/5	16.7% 1/6 • Number of events 1

Other adverse events

Other adverse events
Measure	Liothyronine (T3) n=5 participants at risk liothyronine (T3) Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day	Placebo n=6 participants at risk placebo placebo: placebo
Nervous system disorders excitment	0.00% 0/5	33.3% 2/6 • Number of events 2
General disorders Malaise	0.00% 0/5	16.7% 1/6 • Number of events 1
Psychiatric disorders Insomnia	60.0% 3/5 • Number of events 3	16.7% 1/6 • Number of events 1
Psychiatric disorders Hypersomnia	20.0% 1/5 • Number of events 1	16.7% 1/6 • Number of events 1
Psychiatric disorders Drowsiness	0.00% 0/5	16.7% 1/6 • Number of events 1
Nervous system disorders Tremor	0.00% 0/5	16.7% 1/6 • Number of events 1
Nervous system disorders Tinnitus	0.00% 0/5	16.7% 1/6 • Number of events 1
Cardiac disorders Tachycardia	20.0% 1/5 • Number of events 1	0.00% 0/6
Metabolism and nutrition disorders Increased Appetite	60.0% 3/5 • Number of events 3	0.00% 0/6
Nervous system disorders Headache	0.00% 0/5	33.3% 2/6 • Number of events 2

Additional Information

Raphael J. Braga, MD

The Zucker Hillside Hospital

Phone: 718-4708060

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place