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
|Condition or disease||Intervention/treatment||Phase|
|Depression Bipolar Disorder||Drug: Liothyronine (T3) Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Drug: Liothyronine (T3)
liothyronine (T3) up to 50 micrograms a day
Other Name: cytomel (liothyronine)
Placebo Comparator: 2
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790738
|United States, New York|
|The Zucker Hillside Hospital|
|Glen Oaks, New York, United States, 11004|
|Principal Investigator:||Raphael J Braga, MD||The Zucker Hillside Hospital, North Shore - LIJHS|