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NCT00026585 · ClinicalTrials.gov registry record · Phase 2
Examination of Tamoxifen in Acute Mania in Patients With Bipolar I Disorder
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00026585: Completed Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
NCT00026585 is a Phase 2 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00026585, a Phase 2 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this study is to examine how the drug tamoxifen affects the brain in patients with bipolar I disorder. Bipolar Disorder (BD) is a severe, chronic, and often life-threatening illness for which safe and effective treatments are necessary. The mood stabilizing effects of lithium and valproate have revolutionized the treatment of patients with BD. However, a significant percentage of patients do not respond fully to these drugs, and the biochemical basis for the antimanic and mood-stabilizing actions of lithium and valproate is unclear. Both drugs inhibit protein kinase C (PKC). There is a need to investigate the efficacy of a direct PKC inhibitor in the treatment of acute mania. Tamoxifen is currently the only relatively selective PKC inhibitor available for human use. Participants in this study will be screened with a physical, psychiatric, and eye examination and blood and urine tests. Eligible participants will be hospitalized at the Clinical Center for at least 4 weeks. They will be tapered off all psychiatric medication and kept drug free for 2 to 7 days. They will also be put on a low-monoamine, low-caffeine diet. Participants will be randomly assigned to receive either tamoxifen or placebo (an inactive pill) for 3 weeks. During this time, participants will have daily pulse and blood pressure measurements, several electrocardiograms (EKGs), and blood draws. Weight measurements will be taken at least twice during the study, and caffeine or dextromethorphan will be given at the beginning and end of the study to test how tamoxifen affects the way the body eliminates other medications. Participants will have a physical examination at the end of the study. At the end of this 4-week study, some participants may continue the study and will receive tamoxifen for an additional 3 weeks. At the conclusion of the study, participants' psychiatric status will be reassessed and long-term psychiatric treatment for their mood disorders will be arranged.
Interventions
- DRUG Tamoxifen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2001-11-09 |
| Est. Completion | 2007-11-02 |
| Phase | Phase 2 |
What the finished NCT00026585 record still lists
NCT00026585 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Tamoxifen is the first listed.
NCT00026585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00026585 about?
NCT00026585 is a clinical study titled "Examination of Tamoxifen in Acute Mania in Patients With Bipolar I Disorder". The purpose of this study is to examine how the drug tamoxifen affects the brain in patients with bipolar I disorder. Bipolar Disorder (BD) is a severe, chronic, and often life-threatening illness for which safe and effective treatments are necessary. The mood stabilizing effects of lithium and val...
What is the current status of trial NCT00026585?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2001-11-09. Estimated completion is 2007-11-02.
What interventions are being tested in trial NCT00026585?
The interventions under investigation include: Tamoxifen (DRUG).
Who is sponsoring clinical trial NCT00026585?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00026585's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 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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