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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 is a Phase 2 study that has completed, run by Tufts Medical Center. The registered enrollment target is 119 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00562861
The ClinicalTrials.gov registry entry for NCT00562861 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which citalopram + mood stabilizer is the first listed.
NCT00562861 reports 0 study locations.
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.
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