Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375050
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2006-09-08
Brief Title:
Treatment of Refractory Schizophrenia With Riluzole
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Neuroprotective Treatment of Refractory Schizophrenia With Riluzole 01T-432
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study would evaluate the benefits of riluzole add-on treatment to patients with schizophrenia who are already receiving medications but still experience symptoms Neuroprotective medication riluzole is currently approved for treatment of amyotrophic lateral sclerosis Lou Gehrigs disease a severe neurological illness Due to its unique mechanism of action riluzole if effective in helping the symptoms of schizophrenia would open novel directions in treatment of schizophrenia
Detailed Description:
Schizophrenia is perhaps one of the most debilitating illnesses Over the past years there has been limited improvement in the efficacy of the medications used to treat this disorder In particular the currently available antipsychotic drugs have small efficacy against negative symptoms and cognitive impairment associated with schizophrenia This is critical considering that both negative symptoms and cognitive deficits contribute significantly to social and vocational impairment in schizophrenic patients Furthermore current treatment can not always provide satisfactory control of positive symptoms While various extracellular neurotransmitter systems dopamine 5HT GABA etc have been explored as targets for antipsychotic treatment a substantial body of evidence suggests that neurodegenerative intracellular processes might be responsible for some of the symptoms of schizophrenia resulting in cytopathic effects or inadequate cellular functioning Some of these processes may be triggered by excitotoxic influence of neurotransmitters ie glutamate As many neuroleptic agents currently in use have some neuroprotective properties it is possible to speculate that medications with primarily neuroprotective mode of action might be of additional help in treatment of schizophrenia
Huntingtons disease patients who in its advanced form exhibit some symptoms similar to that of psychotic illness have in a recent small n9 open label study with a neuroprotective drug riluzole shown a temporary improvement in not only motor function but also cognitive and behavioral functioning Seppi 2001
Based on all of the above it seems possible to expect improvement in symptoms of schizophrenia with neuroprotective agents such as riluzole
Riluzole is the only effective medication approved for use in ALS amyotrophic lateral sclerosis Lou Gehrigs disease which is one of the most severe and rapidly progressing neurodegenerative illnesses that affects motor neurons in the brain and spinal cord A subset of ALS is inherited and involves more than 70 different mutations in the antioxidant enzyme superoxide dismutase SOD thereby contributing to reduced antioxidative defense against oxidative injury This results in increased reactive oxygen species level in several organstissues while the bulk of symptomatology is related to degeneration in the subset of CNS neurons Although riluzole is effective in both humans and the transgenic mouse model of familial ALS where it slows decrease in motor power its exact neuroprotective mechanism of action is not known Various studies suggest that riluzole might exert some of its beneficial effect by inhibition of glutamate release inhibition of voltage-gated Na channels but also intracellularly by inhibiting of protein kinase C PKC enzyme that was linked to oxidative neuronal injury Although riluzole is generally well tolerated side effects can occur and are mostly related to gastrointestinal problems hepatotoxicity and asthenia
This 14 week study would evaluate the benefits of riluzole add-on treatment to patients with schizophrenia on neuroleptics with refractory symptoms
Huntingtons disease patients who in its advanced form exhibit some symptoms similar to that of psychotic illness have in a recent small n9 open label study with a neuroprotective drug riluzole shown a temporary improvement in not only motor function but also cognitive and behavioral functioning Seppi 2001
Based on all of the above it seems possible to expect improvement in symptoms of schizophrenia with neuroprotective agents such as riluzole
Riluzole is the only effective medication approved for use in ALS amyotrophic lateral sclerosis Lou Gehrigs disease which is one of the most severe and rapidly progressing neurodegenerative illnesses that affects motor neurons in the brain and spinal cord A subset of ALS is inherited and involves more than 70 different mutations in the antioxidant enzyme superoxide dismutase SOD thereby contributing to reduced antioxidative defense against oxidative injury This results in increased reactive oxygen species level in several organstissues while the bulk of symptomatology is related to degeneration in the subset of CNS neurons Although riluzole is effective in both humans and the transgenic mouse model of familial ALS where it slows decrease in motor power its exact neuroprotective mechanism of action is not known Various studies suggest that riluzole might exert some of its beneficial effect by inhibition of glutamate release inhibition of voltage-gated Na channels but also intracellularly by inhibiting of protein kinase C PKC enzyme that was linked to oxidative neuronal injury Although riluzole is generally well tolerated side effects can occur and are mostly related to gastrointestinal problems hepatotoxicity and asthenia
This 14 week study would evaluate the benefits of riluzole add-on treatment to patients with schizophrenia on neuroleptics with refractory symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None