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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 is a Phase 2 study that has completed, run by Nathan Kline Institute for Psychiatric Research. The registered enrollment target is 8 participants.

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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.

Interventions

  • DRUG Sodium Oxybate

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2008-05
Est. Completion 2009-04
Phase Phase 2

What the Registry Record Tells You About NCT00594256

The ClinicalTrials.gov registry entry for NCT00594256 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nathan Kline Institute for Psychiatric Research, which has 20 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Sodium Oxybate is the first listed.

NCT00594256 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.