Ignite Creation Date:
2024-05-05 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00688324
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2008-05-28
Brief Title:
Biomarker Study of Acamprosate in Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Biomarker Study of Acamprosate in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2019-09
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:
NMDA receptors are brain receptors that are stimulated by glutamate Poorly functioning NMDA receptors are thought to be involved in the pathology of schizophrenia This hypothesis is based on the observation that PCP which blocks the NMDA receptor produces symptoms and cognitive impairments similar to schizophrenia Efforts to enhance the function of the NMDA receptor with glycine and D-cycloserine have met with limited success An alternative approach would be to use the drug acamprosate
Acamprosate FDA-approved for maintenance of sobriety after detoxification from alcohol seems to act through modulation of the NMDA receptor In the lab acamprosate has been noted to act as an antagonist when the NMDA receptors are maximally stimulated but as an agonist when NMDA receptor stimulation is minimal This smart drug action makes acamprosate appealing for use in schizophrenia If acamprosate works as a smart drug in patients then we would predict that it would enhance the function of NMDA receptors in schizophrenia and improve cognition and the symptoms of the illness Additionally acamprosate seems to modulate the NMDA receptor in novel ways distinct from glycine and D-cycloserine
We will also see if the response to acamprosate differs based on whether participants do or do not have a past history of alcohol use disorders
Acamprosate FDA-approved for maintenance of sobriety after detoxification from alcohol seems to act through modulation of the NMDA receptor In the lab acamprosate has been noted to act as an antagonist when the NMDA receptors are maximally stimulated but as an agonist when NMDA receptor stimulation is minimal This smart drug action makes acamprosate appealing for use in schizophrenia If acamprosate works as a smart drug in patients then we would predict that it would enhance the function of NMDA receptors in schizophrenia and improve cognition and the symptoms of the illness Additionally acamprosate seems to modulate the NMDA receptor in novel ways distinct from glycine and D-cycloserine
We will also see if the response to acamprosate differs based on whether participants do or do not have a past history of alcohol use disorders
Detailed Description:
We propose to measure the response of symptoms and cognition in people schizophrenia given acamprosate or placebo We hypothesize that symptoms and cognition will improve following two weeks of acamprosate We will also use proton magnetic resonance spectroscopy MRS to examine the effect of acamprosate on glutamate glutamine GluGln brain levels in people with schizophrenia We hypothesize that GluGln concentrations in people with chronic schizophrenia will increase following two weeks of treatment with acamprosate
The proposed study will consist of 50 individuals with chronic schizophreniaschizoaffective disorder 18-55 years old from inoutpatient programs at the Maryland Psychiatric Research Center MPRC The dose of acamprosate will follow manufacturer recommendations with two 333mg tablets given three times per day MRS will be acquired from areas involved in schizophrenia dorsolateral-prefrontal cortex DLPFC and anterior cingulate cortex ACC at baseline and week two Symptom ratings and cognitive testing will occur at baseline and be repeated at week two
The proposed study will consist of 50 individuals with chronic schizophreniaschizoaffective disorder 18-55 years old from inoutpatient programs at the Maryland Psychiatric Research Center MPRC The dose of acamprosate will follow manufacturer recommendations with two 333mg tablets given three times per day MRS will be acquired from areas involved in schizophrenia dorsolateral-prefrontal cortex DLPFC and anterior cingulate cortex ACC at baseline and week two Symptom ratings and cognitive testing will occur at baseline and be repeated at week two
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R03AA019571 | NIH | None | httpsreporternihgovquickSearchR03AA019571 |