Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000371
Status:
COMPLETED
Last Update Posted:
2014-09-10
First Post:
1999-11-02
Brief Title:
Trial of D-Cycloserine in Schizophrenia
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Six Month Placebo-Controlled Trial of D-Cycloserine Co-Administered With Conventional Antipsychotics in Schizophrenia Patients
Status:
COMPLETED
Status Verified Date:
2014-09
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:
To characterize further the effects of D-cycloserine augmentation of antipsychotic treatment on negative symptoms performance on neurocognitive tasks and on markers for glutamatergic dopaminergic and serotonergic function in serum and cerebrospinal fluid To determine if negative symptoms and cognitive function improve over time if these improvements meaningfully impact quality of life factors if they correlate with markers of neuronal function and if subpopulations can be identified according to response
Dysfunction of glutamatergic neuronal systems has recently been implicated in the pathophysiology of schizophrenia based on the finding that non-competitive inhibitors of the NMDA receptor can reproduce in normals the positive symptoms negative symptoms and cognitive deficits of schizophrenia Furthermore glutamatergic dysfunction may alter forebrain dopaminergic neuronal activity a system central to the antipsychotic action of typical neuroleptics It is believed that enhancing NMDA receptor function by systemic treatment with D-cycloserine a partial agonist at the glycine modulatory site of the NMDA receptor will reduce symptoms in schizophrenia
Sixty schizophrenic outpatients with prominent primary negative symptoms are treated with antipsychotic medication and are randomly assigned to D-cycloserine or placebo for a 6-month fixed-dose trial The primary outcome measure is the total score on the Scale for Assessment of Negative Symptoms SANS A neuropsychological battery which emphasizes tests sensitive to prefrontal cortical function is administered Blood is obtained at several time points and CSF is obtained at Week 8 for assay of concentrations of D-cycloserine glutamate HVA and 5HIAA
Dysfunction of glutamatergic neuronal systems has recently been implicated in the pathophysiology of schizophrenia based on the finding that non-competitive inhibitors of the NMDA receptor can reproduce in normals the positive symptoms negative symptoms and cognitive deficits of schizophrenia Furthermore glutamatergic dysfunction may alter forebrain dopaminergic neuronal activity a system central to the antipsychotic action of typical neuroleptics It is believed that enhancing NMDA receptor function by systemic treatment with D-cycloserine a partial agonist at the glycine modulatory site of the NMDA receptor will reduce symptoms in schizophrenia
Sixty schizophrenic outpatients with prominent primary negative symptoms are treated with antipsychotic medication and are randomly assigned to D-cycloserine or placebo for a 6-month fixed-dose trial The primary outcome measure is the total score on the Scale for Assessment of Negative Symptoms SANS A neuropsychological battery which emphasizes tests sensitive to prefrontal cortical function is administered Blood is obtained at several time points and CSF is obtained at Week 8 for assay of concentrations of D-cycloserine glutamate HVA and 5HIAA
Detailed Description:
To characterize further the effects of D-cycloserine augmentation of antipsychotic treatment on negative symptoms performance on neurocognitive tasks and on markers for glutamatergic dopaminergic and serotonergic function in serum and cerebrospinal fluid To determine if negative symptoms and cognitive function improve over time if these improvements meaningfully impact quality of life factors if they correlate with markers of neuronal function and if subpopulations can be identified according to response
Dysfunction of glutamatergic neuronal systems has recently been implicated in the pathophysiology of schizophrenia based on the finding that non-competitive inhibitors of the NMDA receptor can reproduce in normals the positive symptoms negative symptoms and cognitive deficits of schizophrenia Furthermore glutamatergic dysfunction may alter forebrain dopaminergic neuronal activity a system central to the antipsychotic action of typical neuroleptics It is believed that enhancing NMDA receptor function by systemic treatment with D-cycloserine a partial agonist at the glycine modulatory site of the NMDA receptor will reduce symptoms in schizophrenia
Sixty schizophrenic outpatients with prominent primary negative symptoms are treated with antipsychotic medication and are randomly assigned to D-cycloserine or placebo for a 6-month fixed-dose trial The primary outcome measure is the total score on the Scale for Assessment of Negative Symptoms SANS A neuropsychological battery which emphasizes tests sensitive to prefrontal cortical function is administered Blood is obtained at several time points and CSF is obtained at Week 8 for assay of concentrations of D-cycloserine glutamate HVA and 5HIAA
Dysfunction of glutamatergic neuronal systems has recently been implicated in the pathophysiology of schizophrenia based on the finding that non-competitive inhibitors of the NMDA receptor can reproduce in normals the positive symptoms negative symptoms and cognitive deficits of schizophrenia Furthermore glutamatergic dysfunction may alter forebrain dopaminergic neuronal activity a system central to the antipsychotic action of typical neuroleptics It is believed that enhancing NMDA receptor function by systemic treatment with D-cycloserine a partial agonist at the glycine modulatory site of the NMDA receptor will reduce symptoms in schizophrenia
Sixty schizophrenic outpatients with prominent primary negative symptoms are treated with antipsychotic medication and are randomly assigned to D-cycloserine or placebo for a 6-month fixed-dose trial The primary outcome measure is the total score on the Scale for Assessment of Negative Symptoms SANS A neuropsychological battery which emphasizes tests sensitive to prefrontal cortical function is administered Blood is obtained at several time points and CSF is obtained at Week 8 for assay of concentrations of D-cycloserine glutamate HVA and 5HIAA
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