Schizophrenia Clinical Trial
Official title:
Safety and Efficacy of Fingolimod in Schizophrenia Patients Who Have Suboptimal Responses to Antipsychotic Drug Treatment
This will be a single site safety and proof of concept study conducted at the Indiana University Psychotic Disorders Program. Forty subjects with schizophrenia or schizoaffective disorders will be randomized 1:1 to double-blind treatment with fingolimod or matched placebo for duration of 8 weeks.
Study Design:
This will be a single site safety and proof of concept study conducted at the Indiana
University Psychotic Disorders Program. Forty subjects with schizophrenia or schizoaffective
disorders will be randomized 1:1 to double-blind treatment with fingolimod or matched placebo
for duration of 8 weeks.
All subjects will be admitted to the Indiana Clinical and Translational Sciences Institute
Clinical Research Center (CRC) and remain hospitalized for the first 24 (+/- 2) hours post
initial dose of study medication. The CRC is located in Indiana University Hospital and has
24 hour staffing with nurses skilled in conducting Phase 1 and Phase 2 investigational drug
studies.
Background and Rationale:
Schizophrenia is a severe brain disorder that begins during the teenage years and early
twenties and typically progresses to a life-long chronic illness marked by psychotic
symptoms, cognitive impairment and poor functioning. A leading hypothesis to account for the
symptoms and cognitive dysfunction of this disorder is that abnormalities exist in cortical
circuits, particularly in frontal and temporal areas. An interest in cortical circuitry has
led to a focus on the integrity of cortical white matter tracts as possibly contributing to
the pathophysiology of this illness. Indeed, several lines of evidence have supported
abnormalities in white matter structure and function in schizophrenia. Numerous
myelin-related genes and their functional expression have been associated with schizophrenia.
Moreover, quantitative and qualitative abnormalities in prefrontal cortical oligodendrocytes
have been found in postmortem studies. MRI-determined volumetric reductions in prefrontal
white matter have been reported in schizophrenia. Advances in MRI technology have enhanced
the ability to study white matter pathology in vivo. Diffusion tensor imaging (DTI) and
fractional anisotropy (FA) provides an assessment of the density and integrity of white
matter tracts. Decreased FA has been reported in many de-myelinating diseases including
multiple sclerosis (MS), leukodystrophies, and HIV. Numerous studies using DTI have reported
decrements in FA in schizophrenia with the most consistent abnormalities occurring in frontal
cortical white matter. Also, FA has been shown to be sensitive to therapeutic drug effects in
MS which supports DTI-derived FA as an outcome measure in clinical trials of neuroprotective
agents.
Fingolimod (FTY720, approved as Gilenya™ ) is a sphingosine-1-phosphate (S1P) receptor
modulator and recently licensed in the USA and several other countries for relapsing forms of
multiple sclerosis (MS). It is administered as a once per day oral preparation. In
registration clinical trials, it had positive effects on brain atrophy, MRI-determined axonal
lesions and relapse rates. Significant improvement in the mean number of MRI assessed T1
gadolinium (Gd) enhanced lesions/patient and the percentage of patients free of T1
Gd-enhanced lesions was observed within 6 months of treatment and there was evidence of
clinical improvement as early as 2 months after treatment initiation
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