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NCT00805493 · ClinicalTrials.gov registry record · Phase 2
Double-Blind Placebo-Controlled Trial of Riluzole in Pediatric Bipolar Disorder
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00805493: Clinical Trial Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
NCT00805493 is a Phase 2 study that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00805493, a Phase 2 study, was terminated before completion, sponsored by National Institute of Mental Health (NIMH).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
Pediatric Bipolar Disorder (BD) is uncommon in children. Its symptoms include periods of manic behavior (being overly happy or giddy, feeling grandiose, feeling a decreased need for sleep, having too much energy, moving more than usual, talking fast, having speeded-up thoughts and other symptoms). Sometimes there also is depression (extreme feelings of sadness or irritability, not taking pleasure in things, even ones that used to be enjoyable, feeling worthless or guilty, sleeping too much or having trouble getting to or staying asleep, feeling slowed down or restless, having wishes to be dead or suicidal ideas, and other symptoms). Pediatric BD is often difficult to treat; children may respond only partially to the medications now available or have too many side effects to tolerate them. Riluzole is a medication that is thought to work on a brain chemical called glutamate that may be involved in symptoms of depression and BD. Previous research studies have shown that riluzole may help adults with BD who have depression and adults who have depression, anxiety disorders, or obsessive-compulsive disorders. Riluzole may also be helpful for children with obsessive-compulsive disorder. However, it has never been given to children with BD. This study will evaluate the effectiveness of riluzole in 80 patients between 9 and 17 years of age who have BD and symptoms of anxiety. Participants must have tried at least two other medications that have not been effective. The study will consist of four phases carried out over 4 to 5 months. Most children will be inpatients at the Pediatric Behavioral Health Unit for at least part of the study. In Phase 1, each patient will undergo blood and urine tests, and will gradually taper off his or her medication. The duration of this phase depends on the medication that the patient was receiving before starting the study. In Phase 2, the patient will remain off all medication for 1 week. Throughout this time, patients will be monitored
Primary Outcome
This is a clinician rated measure that is a standard in pharmacological trials. the scores range from 1 to 8 with 5 being unchanged, 1 being completely recovered and 8 being markedly worse.
Interventions
- DRUG Riluzole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2008-11 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
Why NCT00805493 stopped before completion
NCT00805493 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Riluzole is the first listed.
NCT00805493 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00805493 about?
NCT00805493 is a clinical study titled "Double-Blind Placebo-Controlled Trial of Riluzole in Pediatric Bipolar Disorder". Pediatric Bipolar Disorder (BD) is uncommon in children. Its symptoms include periods of manic behavior (being overly happy or giddy, feeling grandiose, feeling a decreased need for sleep, having too much energy, moving more than usual, talking fast, having speeded-up thoughts and other symptoms). S...
What is the current status of trial NCT00805493?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2008-11. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00805493?
The interventions under investigation include: Riluzole (DRUG).
Who is sponsoring clinical trial NCT00805493?
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 NCT00805493's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 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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