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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: Completed Phase 2 study, sponsored by Charite University, Berlin, Germany.
NCT01528839 is a Phase 2 study that has completed, run by Charite University, Berlin, Germany. The registered enrollment target is 74 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01528839 record still lists
NCT01528839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01528839 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01528839's enrollment target sits among peer trials
74 920th of 2000 higher than 1,077 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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