Purpose

The purpose of this research study is to find out if people who have been diagnosed with schizophrenia or schizoaffective disorder and are still having symptoms of their illness despite prior treatment can be helped by an intravenously administered drug called Ceftriaxone. This drug (Ceftriaxone) has not been used in the treatment of schizophrenia or schizoaffective disorder before. However it has been associated with improvements in symptoms, such as auditory hallucinations and problems in expressing thoughts, in a small number of people who had both symptoms of schizophenia and a diagnosis of possible past Lyme disease. The ceftriaxone which is an antibiotic was given to the patients because of the history of Lyme disease; it was an unexpected finding that the psychosis symptoms would improve as they did in some (but not all) patients. During this study, patients will be given either the actual drug (Ceftriaxone) or an inactive solution (placebo)through an intravenous (IV) tube; the IV is a flexible plastic tube that is placed into the vein. During the study the patient is expected to continue to take all medications he/she has been on during the prior few months at the same dose. The research treatment is provided at no financial cost to the patient in the inpatient research facility at the NYS Psychiatric Institute.

Type of Study: Clinical Trial
Setting of Study: inpatient
Clinical Trials.gov number: NCT00591318
Providing Clinical Treatment?: Yes
No Cost Treatment?: Yes
Care is provided in languages: English

Study Activities

Filling Out Forms
Computer Tasks
Blood Samples
MRI Scan

Eligibility

Ages Eligible for Study: 18 Years - 55 Years
Genders Eligible for Study: Both
This study is not recruiting Healthy Volunteers.

Criteria

Inclusion Criteria:
Prior to receiving Ceftriaxone a subject must:
• Be on a stable dose of antipsychotic and all other psychiatric medication (except PRN benzodiazepines) for at least 2 months. This is extended to 4 months for those on Clozaril.
NOTE: Patients may be screened and transferred to NYSPI before this 2 month period has passed. However patients will only be started on IV Ceftriaxone after being medication stable for 2 months.
• Have a negative Urine toxicology
• Have had his or her current treatment optimized, i.e. the trials of antipsychotic drugs have been long enough in length that a therapeutic effect would have been seen.
• Can tolerate being away from his or her treating psychiatrist in order to be hospitalized at NYSPI

Location: 
Clinic: Lieber Schizophrenia Research Clinic
Division: Therapeutics

Study chairs or principal investigators:
Brian Fallon MD, Principal Investigator

Co-investigators:
Jeffrey Lieberman, MD,
Lawrence Kegeles, MD, PhD,
Adam Savitz,MD,
Zafar Sharif, MD,
Roberto Gil, MD