Biomarker Study of Acamprosate in Schizophrenia

Completed · Phase 4

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT00688324

Run by

University of Maryland, Baltimore

People needed

36

Starts

2008-06-01

Expected to finish

2012-02-01

Last updated by the study team

2019-09-25

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• VA Maryland Health Care System — Baltimore, Maryland, United States
• Keypoint Community Mental Health Centers- Dundalk — Baltimore, Maryland, United States
• Keypoint Community Mental Health Centers- Catonsville — Baltimore, Maryland, United States
• Maryland Psychiatric Research Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.