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NCT01528839 · ClinicalTrials.gov registry record · Phase 2
Supraphysiological Doses of Levothyroxine as Adjunctive Therapy in Bipolar Depression
A Phase 2 study, sponsored by Charite University, Berlin, Germany.
- Completed
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
NCT01528839 is a Phase 2 study that has completed, run by Charite University, Berlin, Germany. The registered enrollment target is 74 participants.
The verdict
NCT01528839, a Phase 2 study, has completed, sponsored by Charite University, Berlin, Germany.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG L-Thyroxine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2004-03 |
| Est. Completion | 2008-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01528839
The ClinicalTrials.gov registry entry for NCT01528839 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Charite University, Berlin, Germany, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01528839 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01528839 about?
NCT01528839 is a clinical study titled "Supraphysiological Doses of Levothyroxine as Adjunctive Therapy in Bipolar Depression". 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 il...
What is the current status of trial NCT01528839?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2004-03. Estimated completion is 2008-08.
What interventions are being tested in trial NCT01528839?
The interventions under investigation include: Placebo (DRUG), L-Thyroxine (DRUG).
Who is sponsoring clinical trial NCT01528839?
This trial is sponsored by Charite University, Berlin, Germany, which has 2 total clinical trials registered on ClinicalTrials.gov.
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