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Biomarker Study of Acamprosate in Schizophrenia

This study has been completed.
National Alliance for Research on Schizophrenia and Depression
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Bernard Fischer, MD, University of Maryland Identifier:
First received: May 28, 2008
Last updated: September 10, 2012
Last verified: September 2012

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 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biomarker Study of Acamprosate in Schizophrenia

Resource links provided by NLM:

Further study details as provided by Bernard Fischer, MD, University of Maryland:

Primary Outcome Measures:
  • Levels of Glu&Gln, GABA, NAA in select brain regions [ Time Frame: Baseline and after 2 weeks ]

Secondary Outcome Measures:
  • Cognitive Test Performance [ Time Frame: Baseline and after 2 weeks ]
  • Symptom measures [ Time Frame: Baseline and after 2 weeks ]
  • Side-Effect Measures (Including Movement Side-Effects) [ Time Frame: Baseline and after 2 weeks ]

Enrollment: 39
Study Start Date: June 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (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

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 (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.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00688324

United States, Maryland
VA Maryland Health Care System
Baltimore, Maryland, United States, 21201
Keypoint Community Mental Health Centers- Dundalk
Baltimore, Maryland, United States, 21222
Keypoint Community Mental Health Centers- Catonsville
Baltimore, Maryland, United States, 21228
Maryland Psychiatric Research Center
Baltimore, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland
National Alliance for Research on Schizophrenia and Depression
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Bernard A Fischer, M.D. University of Maryland
  More Information

Additional Information:
Responsible Party: Bernard Fischer, MD, Physician, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland Identifier: NCT00688324     History of Changes
Other Study ID Numbers: HP-00043248
R03AA019571 ( U.S. NIH Grant/Contract )
Study First Received: May 28, 2008
Last Updated: September 10, 2012

Keywords provided by Bernard Fischer, MD, University of Maryland:
schizoaffective disorder
NMDA receptor
magnetic resonance spectroscopy

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Alcohol Deterrents processed this record on September 19, 2017