A Phase 2/3 interventional study of L-Thyroxine and Placebo in Bipolar Disorder, sponsored by Charite University, Berlin, Germany. Completed at 5 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-02-08.
Sponsored by Charite University, Berlin, Germany · Phase 2/3, Interventional, and Treatment
There is growing evidence that thyroid axis dysfunction may contribute to the pathophysiology of bipolar illness. Open-label studies have consistently demonstrated that the behavioral expression of bipolar disorder can be modified by a change in thyroid status, and in many instances the course of illness is improved through the use of adjunct thyroid hormone treatment. Recent evidence emerged from acute intervention studies that add-on treatment with supraphysiological doses of levothyroxine is an effective augmenting agent in patients with a major depressive episode. The primary goal of this international multicenter trial (5 sites) is to determine in a 13-week, randomized, placebo-controlled design (1 week single-blind placebo run-in, 6 week double-blind, 6 week open-label) the efficacy and safety of add-on treatment with levothyroxine (300 mcg/d) in combination with mood stabilizer/antidepressant therapy in the treatment of patients with bipolar depression. The main hypotheses is: treatment with levothyroxine will result in a significantly greater mean reduction of HRSD total score and in a higher number of responders and remitters compared to placebo treatment. This proposal will build on our pilot data and provide evidence for the use of levothyroxine as an effective augmentation strategy in the treatment of bipolar depression.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 74 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Placebo
Drug: L-Thyroxine
L-Thyroxine as addon to ongoing stable antidepressant and /or mood stabilizing therapy: week 1: 100 mcg; week 2: 200 mcg: week 3 to week 6: 300 mcg
Mean change in Hamilton Rating Scale for Depression (HRSD, 17 items)
Time frame: baseline and six weeks
Mean change and single items change in the Thyroid Symtom List (TSL)
Time frame: baseline and six weeks
Remission/Response
Rate of Resonders (\>50% decline in HRDS) and Remitters (HRDS- score \< 9)after l-Thyroxine addon treatment
Time frame: six weeks
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany