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| Sponsor: | University of Maryland |
|---|---|
| Collaborators: |
National Alliance for Research on Schizophrenia and Depression National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Information provided by: | University of Maryland |
| ClinicalTrials.gov Identifier: | NCT00688324 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder |
Drug: Acamprosate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Biomarker Study of Acamprosate in Schizophrenia |
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Single Arm
All subjects will have baseline measures, receive acamprosate for 2 weeks, then have measures repeated.
|
Drug: Acamprosate
Acamprosate 333mg, ii tablets PO tid x 2 weeks
Other Name: Campral
|
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 50 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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jen Osing | 410-402-6060 | josing@mprc.umaryland.edu |
| United States, Maryland | |
| Maryland Psychiatric Research Center | Recruiting |
| Baltimore, Maryland, United States, 21228 | |
| Contact: Jen Osing 410-402-6060 josing@mprc.umaryland.edu | |
| Keypoint Community Mental Health Centers- Catonsville | Recruiting |
| Baltimore, Maryland, United States, 21228 | |
| Keypoint Community Mental Health Centers- Dundalk | Recruiting |
| Baltimore, Maryland, United States, 21222 | |
| VA Maryland Health Care System | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Principal Investigator: | Bernard A Fischer, M.D. | University of Maryland |
More Information
| Responsible Party: | Bernard A. Fischer, M.D., Maryland Psychiatric Research Center, University of Maryland School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00688324 History of Changes |
| Other Study ID Numbers: | HP-00043248, R03AA019571 |
| Study First Received: | May 28, 2008 |
| Last Updated: | April 23, 2011 |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
schizophrenia schizoaffective disorder glutamate |
NMDA receptor magnetic resonance spectroscopy acamprosate |
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Acamprosate |
Alcohol Deterrents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
