I haven't found a new one either. I do, however, have this:
clinicaltrials.gov/ct2/show/NCT00591318?term=lyme+disease&rank=14 A Placebo-Controlled Efficacy Study of IV Ceftriaxone for Refractory
Psychosis
This study is currently recruiting participants.
Verified by Research Foundation for Mental Hygiene, December 2007
Sponsors and Collaborators: Research Foundation for Mental Hygiene
National Alliance for Research on Schizophrenia and Depression
Information provided by: Research Foundation for Mental Hygiene
ClinicalTrials.gov Identifier: NCT00591318
Purpose
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.
Condition Intervention Phase
Psychosis
Schizophrenia
Schizoaffective Disorder
Drug: ceftriaxone
Drug: Normal Saline
Phase I
Phase II
MedlinePlus related topics: Psychotic Disorders Schizophrenia
ChemIDplus related topics: Sodium chloride Ceftriaxone
Ceftriaxone Sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject,
Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel
Assignment, Efficacy Study
Official Title: IV Ceftriaxone for Refractory Psychosis: a
Controlled Trial
Further study details as provided by Research Foundation for Mental
Hygiene:
Primary Outcome Measures:
PANNS Score (Total and Positive Symptom) [ Time Frame: Baseline, 2, 4,
6 & 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
MR Spectroscopy [ Time Frame: Baseline and 8 weeks ] [ Designated as
safety issue: No ]
MATRICS [ Time Frame: Baseline and End of Treatment ] [ Designated as
safety issue: No ]
SAPS/SANS [ Time Frame: Baseline and Wk 8 ] [ Designated as safety
issue: No ]
Hamilton Depression Scale [ Time Frame: Baseline and Week 8 ]
[ Designated as safety issue: No ]
Side Effect Checklist [ Time Frame: Baseline & weekly through Wk 8 ]
[ Designated as safety issue: Yes ]
Hamilton Anxiety Scale [ Time Frame: Baseline, weeks 2, 4, 6, 8 ]
[ Designated as safety issue: No ]
MMSE [ Time Frame: Baseline and week 8 ] [ Designated as safety issue:
No ]
CDSS [ Time Frame: Baseline, weeks 2, 4, 6, 8 ] [ Designated as safety
issue: No ]
CGI Change [ Time Frame: Weekly through week 8 ] [ Designated as
safety issue: No ]
YMRS [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue:
No ]
Estimated Enrollment: 28
Study Start Date: August 2007
Estimated Primary Completion Date: August 2009 (Final data
collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
IV Ceftriaxone 2 grams/day Drug: ceftriaxone
2 grams of ceftriaxone given daily, Monday to Friday, excluding major
holidays, for a total of 40 doses
B: Placebo Comparator
IV Placebo (Normal Saline) Drug: Normal Saline
50 cc of normal saline, daily, Monday through Friday, except for major
holidays, for a total of 40 normal saline infusions.
Eligibility
Ages Eligible for Study: 18 Years to 55 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Adult age 18-55 (Self Report)
Persistent positive symptoms of psychosis despite at least three
adequate trials of anti-psychotics as defined by the Texas medical
Algorithm Project - one of which is clozapine unless there is a contra-
indication. (Review of medical records and conversation with prior
treating psychiatrist).
Significant positive symptoms, including delusions and/or
hallucinations. (Clinical evaluation/interview)
Diagnosis of schizophrenia or schizoaffective disorder (DSM-IV
Diagnostic Checklist)
Patients will be on a stable dose of antipsychotic medication for at
least 8 weeks prior to randomization or 4 months if Clozaril (Clinical
evaluation)
Negative Urine Toxicology (Urine collection at the time of initial
evaluation)
Patients on other antidepressants/mood stabilizers (except PRN
benzodiazepines) will be at the same dose for at least 2 months prior
to starting this trial. (Clinical evaluation & record review.)
Patient's current treatment has been optimized (Review of medical
records and conversation with treating psychiatrist)
Patient is likely to tolerate the departure from clinical management
required of study participants (Review of medical records and
conversation with treating psychiatrist)
There is no significant risk of self-injury or violence based on
recent history and current mental state (Review of medical records and
conversation with treating psychiatrist) -
Exclusion Criteria:
Penicillin or cephalosporin allergy (Self-report)
Agitation such that patient is likely to be unable to tolerate having
an IV line in place.(Behavioral Observation)
Current Lyme disease that has not been treated previously. Current or
history of liver, kidney, or gall bladder disease or elevated liver
function test, elevated BUN over/Cr at screening. Unstable medical
illness. History of gall stones (without subsequent cholecystectomy),
hypereosinophilic syndrome, sickle cell disease, immunodeficiency or
blood clotting disorder. History of inflammatory bowel disease, colon
cancer, or C.difficile colitis. (Review of medical history, screening
blood test).
Inability to be an inpatient for at least 8 weeks. (Discussion with
patient (& family if indicated))
A history of IV drug abuse. (Review of medical history)
Inability to provide informed consent. (Capacity will be assessed by a
clinical MD.)
Patients who had received IV antibiotic therapy within the last year
(Review of medical history)
Pregnancy or lactation. For females of child bearing age, the
pregnancy test is performed pre-randomization. Since this test cannot
detect the very early stage of pregnancy (10 day period between
fertilization and implantation), an effective birth control method or
sexual abstinence is required during the 15 days before the MR scan
and randomization. (Interview & urine pregnancy test pre-
randomization)
For subjects participating in the MRSpectroscopy component: Current or
past history of claustrophobia (Interview and history)
For subjects participating in the MRSpectroscopy component Metal
implants or paramagnetic objects contained within the body which may
pose a risk to the subject or interfere with the MR scan, as
determined in consultation with a neuroradiologist and according to
the guidelines set forth in the following reference book commonly used
by neuroradiologists: "Guide to MR procedures and metallic objects",
F.G. Shellock, Lippincott Williams and Wilkins, NY 2001. (Interview
and history)
History of self-injurious behaviour or other behaviour that might
complicate the insertion and maintenance of an angiocath, in the past
2 years (Interview and History)
Patient is currently taking Cyclosporine (Interview and Medical
records review)
-
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier:
NCT00591318
Contacts
Contact: Katy M Harper, M.A. 212-543-5422
harp...@nyspi.cpmc.columbia.edu
Locations
United States, New York
NYS Psychiatric Institute Recruiting
New York, New York, United States, 10032
Principal Investigator: Brian A Fallon, MD
Sub-Investigator: Jeffrey Lieberman, MD
Sub-Investigator: Lawrence Kegeles, MD
Sponsors and Collaborators
Research Foundation for Mental Hygiene
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Brian A Fallon, MD New York State
Psychiatric Institute
More Information
Publications:
Rothstein JD, Patel S, Regan MR, Haenggeli C, Huang YH, Bergles DE,
Jin L, Dykes Hoberg M, Vidensky S, Chung DS, Toan SV, Bruijn LI, Su
ZZ, Gupta P, Fisher PB. Beta-lactam antibiotics offer neuroprotection
by increasing glutamate transporter expression. Nature. 2005 Jan
6;433(7021):73-7.
Responsible Party: Research Foundation for Mental Hygiene ( Brian A
Fallon, MD )
Study ID Numbers: 5418
First Received: December 26, 2007
Last Updated: December 26, 2007
ClinicalTrials.gov Identifier: NCT00591318
Health Authority: United States: Food and Drug
...
