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NCT00591318 · ClinicalTrials.gov registry record · Phase 1
A Placebo-controlled Efficacy Study of IV Ceftriaxone for Refractory Psychosis
A Phase 1 study, sponsored by Research Foundation for Mental Hygiene.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00591318: Clinical Trial Phase 1 study, sponsored by Research Foundation for Mental Hygiene.
NCT00591318 is a Phase 1 study that was terminated before completion, run by Research Foundation for Mental Hygiene. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00591318, a Phase 1 study, was terminated before completion, sponsored by Research Foundation for Mental Hygiene.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Many patients with schizophrenia and schizoaffective disorder have symptoms that persist, including hallucinations or delusions, despite adequate pharmacotherapy with antipsychotic drug. Glutamate is a major excitatory neurotransmitter in the brain that has been implicated in several brain diseases. NMDA antagonist drugs cause symptoms of psychosis in otherwise normal persons. It is postulated that reduced NMDA receptor mediated neurotransmission leads to an increase in synaptic glutamate. Excessive synaptic concentrations of glutamate can produce excitatory neurotoxicity. Agents which reduce excess glutamate activity are neuroprotective. This therapeutic strategy has been applied to schizophrenia through the use of compounds that reduce presynaptic release of glutamate or otherwise decrease excessive postsynaptic stimulation, including lamotrigine, memantine and a m-GLU-R2 agonist (LY354740) with the hypothesized result of a reduction in psychotic symptoms. Recently it was shown that a commonly available antibiotic (ceftriaxone) has the unique neuroprotective function of decreasing the amount of extracellular glutamate in nervous system tissue by increasing the number of glutamate transporter proteins. Our clinical experience with patients who have refractory psychosis and past Lyme disease indicates that in some patients psychosis may improve with IV ceftriaxone therapy. Whether this improvement was due to its antimicrobial or glutamate effect or a placebo effect is uncertain. In a placebo-controlled design, this study investigates the ability of ceftriaxone to decrease psychotic symptoms in patients with refractory psychotic disorders. In addition, the study will examine glutamatergic functional activity before and after treatment using brain imaging with magnetic resonance spectroscopy.
Primary Outcome
Positive and Negative Syndrome Scale (PANSS) - 7 point scale where 1 is absent and 7 is extreme The positive scale has 7 items. Altogether there are 7 items for the total score (range is a minimum of 7 to a maximum of 49). Lower scores indicate better health. We report the Positive scale
Interventions
- DRUG Normal Saline
- DRUG ceftriaxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2007-10-10 |
| Est. Completion | 2011-03-17 |
| Phase | Phase 1 |
Why NCT00591318 stopped before completion
NCT00591318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT00591318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00591318 about?
NCT00591318 is a clinical study titled "A Placebo-controlled Efficacy Study of IV Ceftriaxone for Refractory Psychosis". Many patients with schizophrenia and schizoaffective disorder have symptoms that persist, including hallucinations or delusions, despite adequate pharmacotherapy with antipsychotic drug. Glutamate is a major excitatory neurotransmitter in the brain that has been implicated in several brain diseases....
What is the current status of trial NCT00591318?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2007-10-10. Estimated completion is 2011-03-17.
What interventions are being tested in trial NCT00591318?
The interventions under investigation include: Normal Saline (DRUG), ceftriaxone (DRUG).
Who is sponsoring clinical trial NCT00591318?
This trial is sponsored by Research Foundation for Mental Hygiene, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00591318's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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