SchizophreniaPhase 4NCT00688324
Biomarker Study of Acamprosate in Schizophrenia
A Phase 4 study testing Acamprosate in people with Schizophrenia and Schizoaffective Disorder, run by University of Maryland, Baltimore at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Acamprosate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2008to Feb 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA Maryland Health Care System
Baltimore, Maryland, 21201
Keypoint Community Mental Health Centers- Dundalk
Baltimore, Maryland, 21222
Keypoint Community Mental Health Centers- Catonsville
Baltimore, Maryland, 21228
Maryland Psychiatric Research Center
Baltimore, Maryland, 21228
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Acamprosate
- Keywords
- schizophrenia, schizoaffective disorder, glutamate, NMDA receptor, magnetic resonance spectroscopy, acamprosate
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcamprosateDrug
Also called Campral
Acamprosate 333mg, ii tablets PO tid x 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All subjects will have baseline measures, receive acamprosate for 2 weeks, then have measures repeated. Receives: Drug: Acamprosate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Cingulate Cortex - Choline
Choline brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Measured: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Anterior Cingulate Cortex - Creatinine
Creatinine brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Measured: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Anterior Cingulate Cortex - Glutamate
Glutamate brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Measured: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Anterior Cingulate Cortex - N-acetylaspartate
N-acetylaspartate (NAA) brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Measured: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Anterior Cingulate Cortex - Myo-inositol
Myo-inositol brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Measured: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Right Dorsal Lateral Prefrontal Cortex - Choline
Choline brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Measured: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Right Dorsal Lateral Prefrontal Cortex - Creatinine
Creatinine brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Measured: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Right Dorsal Lateral Prefrontal Cortex - Glutamate
Glutamate brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Measured: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Right Dorsal Lateral Prefrontal Cortex - N-acetylaspartate
N-acetylaspartate (NAA) brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Measured: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Right Dorsal Lateral Prefrontal Cortex - Myo-inositol
Myo-inositol brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Measured: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Left Dorsal Lateral Prefrontal Cortex - Choline
Choline brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Measured: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Left Dorsal Lateral Prefrontal Cortex - Creatinine
Creatinine brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Measured: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Left Dorsal Lateral Prefrontal Cortex - Glutamate
Glutamate brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Measured: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Left Dorsal Lateral Prefrontal Cortex - N-acetylaspartate
N-acetylaspartate (NAA) brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Measured: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Left Dorsal Lateral Prefrontal Cortex - Myo-inositol
Myo-inositol brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Measured: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Fractional Anisotropy Measured With Diffusion Tensor Imaging
Diffusion Tensor Imaging Frational Anisotropy (FA) Measures by Lifetime History of Alcohol Abuse/Dependence and Brain Hemisphere.
Measured: Completion of two scans
Secondary outcomes (4)
BPRS - Symptoms of Psychosis Change in Scores
Symptoms of psychosis were measured with the Brief Psychiatric Rating Scale (BPRS). The items rated for psychosis are "Conceptual Disorganization", "Suspiciousness", "Hallucinatory Behavior", and "Unusual Thought Content". Each item score ranges from "1=Not Present" to "7=Very Severe".
Value at End of Study minus value at Baseline.
Measured: Baseline (Treatment Week 0) and End of Study (Treatment Week 2)
BPRS - Symptoms of Psychosis Total Score
The psychosis total score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.
Measured: Baseline (Treatment Week 0) and End of Study (Treatment Week 2)
SANS - Negative Symptoms of Schizophrenia Total Score
Negative symptoms of schizophrenia measured using the Scale for the Assessment of Negative Symptoms (SANS) Total Score. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.
Measured: Baseline (Treatment Week 0) and End of Study (Treatment Week 2)
Cognitive Impairment
Cognitive tests will include the DigitSymbol Test (evaluating processing speed), California Verbal Learning Test (CVLT; evaluating verbal learning and episodic memory), and NBack (evaluating working memory).
Digit Symbol scaled scores range from 1 to 19, with the larger numbers indicating better performance.
On the CVLT, the delayed recognition score ranges from 0 to 16, with the larger numbers indicating better performance.
On the NBack test, subjects were asked to recall items 0-back, 1-back, and 2-back in a sequence. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower.
Measured: Change from Baseline (Treatment Week 0) to End of Study (Treatment Week 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Robert Buchanan, University of Maryland, Baltimore
- Investigators
- Bernard A Fischer, M.D., Principal investigator, Food and Drug Administration (FDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688324
- Sponsor's protocol ID
- HP-00043248
- Other IDs
- R03AA019571
- Status last verified
- Sep 2019
- First submitted
- 28 May 2008
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Study of Acamprosate in Schizophrenia
- ClinicalTrials.gov ID
- NCT00688324
- Acronym / sponsor ID
- HP-00043248
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, schizoaffective disorder, glutamate, NMDA receptor, magnetic resonance spectroscopy, acamprosate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jun 2008 (actual)
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Jun 2008 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: AcamprosateAll subjects will have baseline measures, receive acamprosate for 2 weeks, then have measures repeated. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcamprosateAlso: CampralAcamprosate 333mg, ii tablets PO tid x 2 weeks | Drug | Single Arm |
Primary outcome
Anterior Cingulate Cortex - Choline
Time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Choline brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Anterior Cingulate Cortex - Creatinine
Time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Creatinine brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Anterior Cingulate Cortex - Glutamate
Time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Glutamate brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Anterior Cingulate Cortex - N-acetylaspartate
Time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
N-acetylaspartate (NAA) brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Anterior Cingulate Cortex - Myo-inositol
Time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Myo-inositol brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Anterior Cingulate Cortex (ACC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Right Dorsal Lateral Prefrontal Cortex - Choline
Time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Choline brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Right Dorsal Lateral Prefrontal Cortex - Creatinine
Time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Creatinine brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Right Dorsal Lateral Prefrontal Cortex - Glutamate
Time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Glutamate brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Right Dorsal Lateral Prefrontal Cortex - N-acetylaspartate
Time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
N-acetylaspartate (NAA) brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Right Dorsal Lateral Prefrontal Cortex - Myo-inositol
Time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Myo-inositol brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Right Dorsal Lateral Prefrontal Cortex (R DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Left Dorsal Lateral Prefrontal Cortex - Choline
Time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Choline brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Left Dorsal Lateral Prefrontal Cortex - Creatinine
Time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Creatinine brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Left Dorsal Lateral Prefrontal Cortex - Glutamate
Time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Glutamate brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Left Dorsal Lateral Prefrontal Cortex - N-acetylaspartate
Time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
N-acetylaspartate (NAA) brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Left Dorsal Lateral Prefrontal Cortex - Myo-inositol
Time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)
Myo-inositol brain metabolite levels between those with and without a lifetime history of prior alcohol abuse/dependence in the Left Dorsal Lateral Prefrontal Cortex (L DLPFC) using Magnetic Resonance Spectroscopy (MRS). Metabolite concentration was calculated from the MRS signals and reported in "mM".
Fractional Anisotropy Measured With Diffusion Tensor Imaging
Time frame: Completion of two scans
Diffusion Tensor Imaging Frational Anisotropy (FA) Measures by Lifetime History of Alcohol Abuse/Dependence and Brain Hemisphere.
4 secondary outcomes
BPRS - Symptoms of Psychosis Change in Scores
Time frame: Baseline (Treatment Week 0) and End of Study (Treatment Week 2)
BPRS - Symptoms of Psychosis Total Score
Time frame: Baseline (Treatment Week 0) and End of Study (Treatment Week 2)
SANS - Negative Symptoms of Schizophrenia Total Score
Time frame: Baseline (Treatment Week 0) and End of Study (Treatment Week 2)
Cognitive Impairment
Time frame: Change from Baseline (Treatment Week 0) to End of Study (Treatment Week 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Maryland Psychiatric Research CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard A Fischer, M.D. principal investigator
Food and Drug Administration (FDA)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acamprosate in people with Schizophrenia and Schizoaffective Disorder, run by University of Maryland, Baltimore at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior Cingulate Cortex - Choline (time frame: Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.