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| ID | Type | Description | Link |
|---|---|---|---|
| R03AA019571 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | All subjects will have baseline measures, receive acamprosate for 2 weeks, then have measures repeated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acamprosate | Drug | Acamprosate 333mg, ii tablets PO tid x 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 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". | 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". | 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". | 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". |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Treatment Week 0) and End of Study (Treatment Week 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard A Fischer, M.D. | Food and Drug Administration (FDA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Maryland Health Care System | Baltimore | Maryland | 21201 | United States | ||
| Keypoint Community Mental Health Centers- Dundalk |
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| Label | URL |
|---|---|
| Maryland Psychiatric Research Center | View source |
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There were 39 subjects who signed consent for the study. Three subjects were excluded prior to entering the study: two subjects refused to continue and one subject was hospitalized. Thirty six subjects entered the first phase of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | All subjects will have baseline measures, receive acamprosate for 2 weeks, then have measures repeated. Acamprosate: Acamprosate 333mg, ii tablets PO tid x 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Screening | All subjects will have baseline measures |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Date of birth was not recorded for eight participants who gave consent for screening but did not complete the study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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". | Subjects entering baseline screening minus the two subjects with missing alcohol abuse history. | Posted | Mean | Standard Deviation | mM | Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2) |
|
Overall study of 6 weeks.
Reportable adverse events (AEs) are defined as any harm experienced by a study participant, which in the opinion of the investigator is unexpected and probably related to the research procedures. None of our AEs met these criteria.
Participants are systematically monitored for any increases the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | All subjects will have baseline measures, receive acamprosate for 2 weeks, then have measures repeated. Acamprosate: Acamprosate 333mg, ii tablets PO tid x 2 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perceived increase in essential tremor | Nervous system disorders | Systematic Assessment | Subject had a perceived increase in their essential tremor that they attributed to the study medication. Subject refused to continue participation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert W. Buchanan, M.D. | Maryland Psychiatric Research Center | 410-402-7876 | rwbuchanan@som.umaryland.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077443 | Acamprosate |
| ID | Term |
|---|---|
| D013654 | Taurine |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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| 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". | 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". | 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". | 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". | 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". | 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". | 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". | 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". | 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". | 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". | 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. | Completion of two scans |
| 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. | 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. | 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. | Change from Baseline (Treatment Week 0) to End of Study (Treatment Week 2) |
| Baltimore |
| Maryland |
| 21222 |
| United States |
| Keypoint Community Mental Health Centers- Catonsville | Baltimore | Maryland | 21228 | United States |
| Maryland Psychiatric Research Center | Baltimore | Maryland | 21228 | United States |
| Count of Participants |
| Participants |
|
| Age, Continuous | Date of birth was not recorded for eight participants who gave consent for screening but did not complete the study. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Alcohol Abuse History | Number | participants |
|
No Lifetime History of Alcohol Abuse/Dependence
|
|
| Primary | 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". | Subjects entering baseline screening minus the two subjects with missing alcohol abuse history. | Posted | Mean | Standard Deviation | mM | Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2) |
|
|
|
| Primary | 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". | Subjects entering baseline screening minus the two subjects with missing alcohol abuse history. | Posted | Mean | Standard Deviation | mM | Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2) |
|
|
|
| Primary | 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". | Subjects entering baseline screening minus the two subjects with missing alcohol abuse history. | Posted | Mean | Standard Deviation | mM | Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2) |
|
|
|
| Primary | 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". | Subjects entering baseline screening minus the two subjects with missing alcohol abuse history. | Posted | Mean | Standard Deviation | mM | Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2) |
|
|
|
| Primary | 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". | Usable scan data. | Posted | Mean | Standard Deviation | mM | Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2) |
|
|
|
| Primary | 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". | Usable scan data. | Posted | Mean | Standard Deviation | mM | Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2) |
|
|
|
| Primary | 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". | Usable scan data. | Posted | Mean | Standard Deviation | mM | Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2) |
|
|
|
| Primary | 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". | Usable scan data. | Posted | Mean | Standard Deviation | mM | Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2) |
|
|
|
| Primary | 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". | Usable scan data. | Posted | Mean | Standard Deviation | mM | Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2) |
|
|
|
| Primary | 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". | Usable scan data. | Posted | Mean | Standard Deviation | mM | Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2) |
|
|
|
| Primary | 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". | Usable scan data. | Posted | Mean | Standard Deviation | mM | Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2) |
|
|
|
| Primary | 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". | Usable scan data. | Posted | Mean | Standard Deviation | mM | Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2) |
|
|
|
| Primary | 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". | Usable scan data. | Posted | Mean | Standard Deviation | mM | Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2) |
|
|
|
| Primary | 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". | Usable scan data. | Posted | Mean | Standard Deviation | mM | Baseline screening (Scan 1) and again after 2 weeks of Acamprosate treatment (Scan 2) |
|
|
|
| Primary | Fractional Anisotropy Measured With Diffusion Tensor Imaging | Diffusion Tensor Imaging Frational Anisotropy (FA) Measures by Lifetime History of Alcohol Abuse/Dependence and Brain Hemisphere. | Subjects completing study (both scans). | Posted | Mean | Standard Deviation | FA | Completion of two scans |
|
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|
| Secondary | 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. | Subjects completing the BPRS rating at Baseline and End of Study. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Treatment Week 0) and End of Study (Treatment Week 2) |
|
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| Secondary | 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. | Subjects completing BPRS rating at each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Treatment Week 0) and End of Study (Treatment Week 2) |
|
|
|
| Secondary | 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. | Subjects completing the SANS assessment at each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Treatment Week 0) and End of Study (Treatment Week 2) |
|
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| Secondary | 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. | Subjects who completed cognitive testing at both study time points. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline (Treatment Week 0) to End of Study (Treatment Week 2) |
|
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|
| 0 |
| 36 |
| 6 |
| 36 |
|
| Claustrophobia in MRI scan | Psychiatric disorders | Non-systematic Assessment | Subject became claustrophobic in the MRI scanner. Refused to continue participation. |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Restlessness | General disorders | Systematic Assessment |
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| Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| Scan 2 |
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| Scan 2 |
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| Hallucinations Change |
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| Unusual Thought Content Change |
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| End of study |
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| Change |
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| End of study |
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| Change |
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| Change in NBack 2-Back Total Hits |
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| Change in DigitSymbol Scaled Score |
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| Change in CVLT Total Recall |
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