Biomarker Study of Acamprosate in Schizophrenia - NCT00688324-21201 (Clinical Trial 381798)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy381798.aspx
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| City: |
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Baltimore |
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State:
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MD |
| Zip Code: |
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21201 |
| Conditions: |
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Schizophrenia - Schizoaffective Disorder |
| Purpose: |
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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.
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| Study summary: |
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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 (Glu&Gln) brain levels in people
with schizophrenia. We hypothesize that Glu&Gln concentrations in people with chronic
schizophrenia will increase following two weeks of treatment with acamprosate.
The proposed study will consist of 40 individuals with chronic schizophrenia/schizoaffective
disorder, 18-55 years old, from in/outpatient 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. |
| Criteria: |
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Inclusion Criteria:
- DSM-IV diagnosis of schizophrenia/schizoaffective disorder
- Age 18-55 years
- Male or female
- Any Race/ethnicity
- Participants will be analyzed separately depending on whether they do or do not have
a history of an alcohol use disorder
Exclusion Criteria:
- Pregnant/nursing females or females not using adequate birth control
- Documented history of mental retardation/severe neurological disorder/head injury
with loss of consciousness
- DSM-IV diagnosis of substance dependence in previous six months/abuse in the previous
three months (except nicotine)
- Serious suicidal risk in the previous six months
- History of renal failure/creatinine clearance of less than 50mL/min
- Current treatment with clozapine
- Contraindication to MRI scanning. |
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| Study is available at: |
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VA Maryland Health Care System
Baltimore, MD 21201
United States
Primary Contact:
Jen Osing
Email: josing@mprc.umaryland.edu
Phone: 410-402-6060 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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