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NCT00594256 · ClinicalTrials.gov registry record · Phase 2
Sodium Oxybate in Schizophrenia With Insomnia
A Phase 2 study, sponsored by Nathan Kline Institute for Psychiatric Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT00594256: Completed Phase 2 study, sponsored by Nathan Kline Institute for Psychiatric Research.
NCT00594256 is a Phase 2 study that has completed, run by Nathan Kline Institute for Psychiatric Research. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00594256, a Phase 2 study, has completed, sponsored by Nathan Kline Institute for Psychiatric Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
The present protocol proposes study of the recently approved compound sodium oxybate (Xyrem), a gamma-aminobutyric acid type b (GABAB) and a g-hydroxybutyric acid (GHB) receptor agonist, for the study of persistent symptoms of schizophrenia. Sodium oxybate is a central nervous system depressant currently approved for treatment of narcolepsy associated with cataplexy and excessive daytime sleepiness. In addition to evaluating effects on sodium oxybate on persistent symptoms and neurocognitive deficits in schizophrenia, the study will test the hypothesis that this medication may be particularly effective in combating Insomnia Related to Schizophrenia, and in normalizing symptomatic and polysomnographic manifestations of sleep-related brain dysfunction in schizophrenia.
Primary Outcome
This rating scale generates a global sleep-quality score, as well as scores on 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The 19 items are combined to form seven "component" scores, each of which has a range of O-3 points. The seven component scores are then added to yield one "global" score, with a range of O-21 points, "0" indicating no difficulty and
Interventions
- DRUG Sodium Oxybate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2008-05 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
What the finished NCT00594256 record still lists
NCT00594256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Sodium Oxybate is the first listed.
NCT00594256 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00594256 about?
NCT00594256 is a clinical study titled "Sodium Oxybate in Schizophrenia With Insomnia". The present protocol proposes study of the recently approved compound sodium oxybate (Xyrem), a gamma-aminobutyric acid type b (GABAB) and a g-hydroxybutyric acid (GHB) receptor agonist, for the study of persistent symptoms of schizophrenia. Sodium oxybate is a central nervous system depressant curr...
What is the current status of trial NCT00594256?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2008-05. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00594256?
The interventions under investigation include: Sodium Oxybate (DRUG).
Who is sponsoring clinical trial NCT00594256?
This trial is sponsored by Nathan Kline Institute for Psychiatric Research, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00594256's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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