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NCT00562861 · ClinicalTrials.gov registry record · Phase 2
Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram
A Phase 2 study, sponsored by Tufts Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 119
- Enrollment target
NCT00562861: Completed Phase 2 study, sponsored by Tufts Medical Center.
NCT00562861 is a Phase 2 study that has completed, run by Tufts Medical Center. The registered enrollment target is 119 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00562861, a Phase 2 study, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 119 participants
- Enrollment target
Study Summary
Bipolar depression is one of the least studied depressive illnesses. The standard practice for many doctors is to use antidepressant medicines, but there are few studies on the long-term results of these medicines. The goal of this study is to look at how effective and safe these medicines are in treating bipolar depression when taken with a mood stabilizer medicine. The drug being studied is citalopram, also known as Celexa. Celexa is FDA approved for the treatment of major depression, but is not FDA approved for the treatment of bipolar depression. It is, however, standard practice for many doctors is to use antidepressants, like Celexa, to treat their patients with bipolar disorder depression. The drug will be studied in three ways. We will see if it helps treat depressive symptoms. We will see how the drug affects the brain using PET and fMRI scans. Finally, we will look at the possibility that there may be a gene that could predict if a person would get better taking the drug using genetics.
Primary Outcome
Montgomery Asberg Depression Rating scale assessed in mixed effects regression model. The total range for the scale is 0 to 60. Lower values involve less depression, while higher values involve worse depression. The change in the MADRS scale is interpreted as higher values meaning better outcomes, because more depressive symptoms are improved.
Interventions
- DRUG citalopram + mood stabilizer
- DRUG placebo + mood stabilizer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2007-11 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT00562861 record still lists
NCT00562861 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 2 interventions - of which citalopram + mood stabilizer is the first listed.
NCT00562861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00562861 about?
NCT00562861 is a clinical study titled "Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram". Bipolar depression is one of the least studied depressive illnesses. The standard practice for many doctors is to use antidepressant medicines, but there are few studies on the long-term results of these medicines. The goal of this study is to look at how effective and safe these medicines are in tr...
What is the current status of trial NCT00562861?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 119 participants. The study started on 2007-11. Estimated completion is 2014-07.
What interventions are being tested in trial NCT00562861?
The interventions under investigation include: citalopram + mood stabilizer (DRUG), placebo + mood stabilizer (DRUG).
Who is sponsoring clinical trial NCT00562861?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00562861's enrollment target sits among peer trials
119 618th of 2000 higher than 1,383 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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