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| ID | Type | Description | Link |
|---|---|---|---|
| 107865 | Other Identifier | FDA IND |
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| Name | Class |
|---|---|
| Center de Neurosciences Psychiatrique, Lausanne, Switzerland | UNKNOWN |
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The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur during the pre-illness phase and around the transition to psychosis. Therefore, studying new treatments that could target changes occurring during this period is of critical importance.
Aims:
Does add-on NAC treatment in early psychosis influence:
The study proposes that a glutathione deficit leading to an abnormal response to oxidative stress is a vulnerability factor, combined with other brain specific factors, in brain functioning of some individuals with schizophrenia (Do et al., 2010). N-acetyl-cysteine is hypothesized to cross the blood-brain barrier and increase glutathione in the brain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| n-acetyl-cysteine | Active Comparator | N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks |
|
| Placebo | Placebo Comparator | matching effervescent tablets in water 2 in am and 1 in pm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| n-acetylcysteine | Drug | 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Negative Symptoms of Schizophrenia as Measured on the PANSS | Positive and Negative Symptom Scale was used to assess psychopathology. The sum of items N1 - N7 including N1) blunted affect, N2) emotional withdrawal, N3) poor rapport, N4) passive apathetic social withdrawal, N5) difficulty in abstract thinking, N6) lack of spontaneity and flow of conversation, and N7) sterotyped thinking were used to analyze negative symptoms of schizophrenia and were assessed for the previous week: RATING SCALE 1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 . | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive Symptoms (PANSS) | Positive and Negative Symptom Scale was used to assess psychopathology. The Positive symptom subscale of schizophrenia includes the sum of items P1 -P7 including P1) Delusions, P2) conceptual Disorganization, P3) Hallunicatory Behavior, P4) Excitement, P5) Grandiosity, P6) Suspiciousness and Persecution, and P7) Hostility and were assessed for the previous week: RATING SCALE 1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 . |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Cousins, PhD, APRN | Beth Israel Deaconess Medical Center | Study Director |
| T. U. Wilson Woo, MD, PhD | Harvard Medical School (HMS and HSDM) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States | ||
| Massachusetts Mental Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20436260 | Background | Do KQ, Conus P, Cuenod M. Redox dysregulation and oxidative stress in schizophrenia: nutrigenetics as a challenge in psychiatric disease prevention. World Rev Nutr Diet. 2010;101:131-153. doi: 10.1159/000314518. Epub 2010 Apr 30. No abstract available. |
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320 signed consent 133 declined to participate 124 excluded - 65 by Physician decision, 59 subject withdrew 63 met all inclusion and no exclusion criteria 31 to NAC and 30 to placebo
Participants were recruited at two sites, Lausanne University Hospital, Department of Psychiatry, Lausanne, Switzerland and at the Commonwealth Research Center of Beth Israel Deaconess Medical Center Boston, Massachusetts
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| ID | Title | Description |
|---|---|---|
| FG000 | N-acetyl-cysteine | N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM |
| FG001 | Placebo | matching effervescent tablets in water 2 in am and 1 in pm n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization |
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| |||||||||||||||||||||
| Double Blind (Visits 1-7) |
| ||||||||||||||||||||||
| 1 Month Post Study Medication |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | N-acetyl-cysteine | N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Negative Symptoms of Schizophrenia as Measured on the PANSS | Positive and Negative Symptom Scale was used to assess psychopathology. The sum of items N1 - N7 including N1) blunted affect, N2) emotional withdrawal, N3) poor rapport, N4) passive apathetic social withdrawal, N5) difficulty in abstract thinking, N6) lack of spontaneity and flow of conversation, and N7) sterotyped thinking were used to analyze negative symptoms of schizophrenia and were assessed for the previous week: RATING SCALE 1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 . | Analysis was done with those who completed the 6 month treatment protocol. | Posted | Mean | Standard Deviation | units on a scale | at 6 months |
|
Baseline and 6 months
Adverse Events were evaluated every month for 6 months and 1 month post treatment
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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 | N-acetyl-cysteine | N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tremor | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larry Seidman, PhD | Beth Israel Deaconess Medical Center | 617 754-1238 | lseidman@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo tablets are placed in water or juice in the AM and PM |
|
| at 6 months |
| Global Assessment of Functioning (GAF) | Measure Description: Clinical Measure of Global level of Symptoms (Sx) and Functioning from 1 (Worst) to 100 (Best) in groups of 10: 100 - 91: Superior functioning 90 - 81: Absent or minimal Sx 80 - 71: If symptoms are present and expected 70 - 61:Some mild Sx 60 - 51: Moderate Sx 50 - 41: Serious Sx 40 - 31: Some impairment in reality testing or communication 30 - 21: Behavior is considerably influenced by delusions or hallucinations 20 - 11: Some danger of hurting self or others 10 - 1: Persistent danger of severely hurting self or others | at 6 months |
| Social and Occupational Functioning Assessment Scale (SOFAS) | Measure of social and occupational functioning using the Social and Occupational Functioning Assessment Scale Measure Description: Rating of Overall Social and Occupational Functioning on a scale of 1 (worst) to 100 (best) in groups of 10: 100-91: Superior functioning 90-81: Good functioning 80-71: Slight impairment 70-61: Some difficulty 60-51: Moderate difficulty 50-41: Serious impairment 40-31: Major impairment 30-21: Inability to function in almost all areas 20-11: Unable to function independently 10-1: Unable to function without harming self or others | at 6 months |
| Change in Cognition and Working Memory (MATRICS) Speed of Processing | The MATRICS is neurocognitive battery designed to assess cognition. Processing speed is a composite score including the following tests: Trail Making Test, BACS: Symbol Coding, Category Fluency: Animal Naming. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. | at 6 months |
| Change in Cognition and Working Memory (MATRICS) Working Memory | The MATRICS is neurocognitive battery designed to assess cognition. Working Memory score is a composite score based on the following sub-test WMS-III Spatial Span and Letter-Number Span. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. | at 6 months |
| Change in Cognition and Working Memory (MATRICS) Attention and Vigilance | The MATRICS is neurocognitive battery designed to assess cognition. Sustained attention and Vigilance is a composite score based on the Continuous Performance Test -Identical Pairs. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. | at 6 months |
| Change in Cognition and Working Memory (MATRICS) Verbal Learning | The MATRICS is neurocognitive battery designed to assess cognition. Verbal Learning is a composite score based on the Hopkins Verbal Learning Test-Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. | at 6 months |
| Change in Cognition and Working Memory (MATRICS) Visual Learning | The MATRICS is neurocognitive battery designed to assess cognition. Visual Learning is a composite score based on the Brief Visuospatial Memory test - Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. | at 6 months |
| Change in Cognition and Working Memory (MATRICS) Reasoning and Problem Solving | The MATRICS is neurocognitive battery designed to assess cognition. Problem Solving is a composite score based on the NAB Mazes. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. | at 6 months |
| Change in Blood Level of Glutathione | Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. The level of glutathione is measured in blood cells. | at 6 months |
| Blood Plasma Level of Cysteine | Cysteine is an amino acid, a building block for proteins and is used throughout the body and was measured in blood plasma. | at 6 months |
| GPxbc Glutathione Peroxidase Activity in Blood Cells | GPxBC is a measurement of glutathiione peroxidase enzymatic activity in glutathione synthesis and the redox system in blood cells. Measured as umol/min/gHb from blood cells. | at 6 months |
| Glutamine Brain Level for NAC Group | Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate. | at 6 months |
| Glutamine Brain Level for Placebo Group | Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate. | at 6 months |
| Glutamate Brain Level for NAC Group | Brain marker, glutamate, was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutamate is an excitatory neurotransmitter in the brain. | at 6 months |
| Glutamate Brain Level for Placebo Group | Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate. | at 6 months |
| Glutathione Brain Level for NAC Group | measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. | at 6 months |
| Glutathione Brain Level for Placebo Group | measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. | at 6 months |
| Myo-Inositol Brain Level for the NAC Group | Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate. | at 6 months |
| Myo-Inositol Brain Level for Placebo Group | Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate. | at 6 months |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Stopped After First Visit |
|
| Didn't Complete at Least 1 Visit |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
matching effervescent tablets in water 2 in am and 1 in pm
n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Positive and Negative Symptom Scale (PANSS) | Clinical Measure of Positive (7 items P1-P7) Negative Symptoms (7 items N1-N7) General Psychopathology Symptoms (G1-G16) total of 30 items Assessed in the previous week: RATING SCALE 1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 30 and the highesr possible score is 210. | Mean | Standard Deviation | units on a scale |
|
| Global Assessment of Functioning (GAF) | Clinical Measure of Global level of Symptoms (Sx) and Functioning from 1 (Worst) to 100 (Best) in groups of 10: 100 - 91: Superior functioning 90 - 81: Absent or minimal Sx 80 - 71: If symptoms are present and expected 70 - 61:Some mild Sx 60 - 51: Moderate Sx 50 - 41: Serious Sx 40 - 31: Some impairment in reality testing or communication 30 - 21: Behavior is considerably influenced by delusions or hallucinations 20 - 11: Some danger of hurting self or others 10 - 1: Persistent danger of severely hurting self or others | Mean | Standard Deviation | units on a scale |
|
| Duration of Psychosis | Duration of time in days since onset of psychosis | Mean | Standard Deviation | days |
|
| Social and Occupational Functioning Assessment Scale (SOFAS) | Rating of Overall Social and Occupational Functioning on a scale of 1 (worst) to 100 (best) in groups of 10: 100-91: Superior functioning 90-81: Good functioning 80-71: Slight impairment 70-61: Some difficulty 60-51: Moderate difficulty 50-41: Serious impairment 40-31: Major impairment 30-21: Inability to function in almost all areas 20-11: Unable to function independently 10-1: Unable to function without harming self or others | Mean | Standard Deviation | units on a scale |
|
| MATRICS Consensus Cognitive Battery (MCCB) excluding MISCEIT managing emotions test) | The MCCB has 6 cognitive factors including: 1) processing speed (Trail Making Test, BACS: Symbol Coding, Category Fluency: Animal Naming), 2) sustained attention (Continuous Performance Test -Identical Pairs), 3) working memory (WMS-III Spatial Span and Letter-Number Span), 4) verbal learning (Hopkins Verbal Learning Test-Revised: Immediate Recall), 5) visual learning (Brief Visuospatial Memory test - Revised: Immediate Recall) and 6) problem solving (NAB Mazes). The T-score of 50 is an average score. Scores below 50 indicates cognitive processing lower than age matched healthy populations. | Numbers in each group analyzed based on those who completed baseline and post testing. | Mean | Standard Deviation | Standardized T Scores |
|
| Antipsychotic Medication Chlorpromazine Equivalents | Dose of current antipsychotic medication in chlorpromazine equivalents | Mean | Standard Deviation | milligrams |
|
| Blood Marker - Cysteine | Cysteine is an amino acid, a building block for proteins and is used throughout the body and was measured in blood plasma. | Mean | Standard Deviation | uM (micrometer) |
|
| Blood Marker - GPxbc- Glutathione peroxidase | GPxBC is a measurement of glutathiione peroxidase enzymatic activity in glutathione synthesis and the redox system in blood cells. Measured as umol/min/gHb from blood cells. | Mean | Standard Deviation | umol/min/gHb |
|
| Blood Marker - Glutathione | Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. The level of glutathione is measured in blood cells. | Mean | Standard Deviation | mM (millimolar) in blood cells |
|
| Brain Marker - Glutamine and myo-Inositol | Brain levels of glutamine and myo-Inositol were measured using Magnetic ResonanceSpectroscopy (H-MRS), both are chemicals that work to protect the brain from high levels of excitatory chemicals such as glutamate. | MRS was completed on fewer participants. | Mean | Standard Deviation | mM (millimolar) |
|
| Brain Marker - Glutathione and Glutamate | Brain markers, glutathione and glutamate were measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. Glutamate is an excitatory neurotransmitter in the brain. | Only 25 participants had the MRS. | Mean | Standard Deviation | mM (millimolar) |
|
| OG001 | Placebo | matching effervescent tablets in water 2 in am and 1 in pm n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM |
|
|
|
| Secondary | Change in Positive Symptoms (PANSS) | Positive and Negative Symptom Scale was used to assess psychopathology. The Positive symptom subscale of schizophrenia includes the sum of items P1 -P7 including P1) Delusions, P2) conceptual Disorganization, P3) Hallunicatory Behavior, P4) Excitement, P5) Grandiosity, P6) Suspiciousness and Persecution, and P7) Hostility and were assessed for the previous week: RATING SCALE 1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 . | Analysis was done with participants who completed the 6 month treatment phase | Posted | Mean | Standard Deviation | units on a scale | at 6 months |
|
|
|
|
| Secondary | Global Assessment of Functioning (GAF) | Measure Description: Clinical Measure of Global level of Symptoms (Sx) and Functioning from 1 (Worst) to 100 (Best) in groups of 10: 100 - 91: Superior functioning 90 - 81: Absent or minimal Sx 80 - 71: If symptoms are present and expected 70 - 61:Some mild Sx 60 - 51: Moderate Sx 50 - 41: Serious Sx 40 - 31: Some impairment in reality testing or communication 30 - 21: Behavior is considerably influenced by delusions or hallucinations 20 - 11: Some danger of hurting self or others 10 - 1: Persistent danger of severely hurting self or others | Posted | Mean | Standard Deviation | units on a scale | at 6 months |
|
|
|
|
| Secondary | Social and Occupational Functioning Assessment Scale (SOFAS) | Measure of social and occupational functioning using the Social and Occupational Functioning Assessment Scale Measure Description: Rating of Overall Social and Occupational Functioning on a scale of 1 (worst) to 100 (best) in groups of 10: 100-91: Superior functioning 90-81: Good functioning 80-71: Slight impairment 70-61: Some difficulty 60-51: Moderate difficulty 50-41: Serious impairment 40-31: Major impairment 30-21: Inability to function in almost all areas 20-11: Unable to function independently 10-1: Unable to function without harming self or others | Posted | Mean | Standard Deviation | units on a scale | at 6 months |
|
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|
|
| Secondary | Change in Cognition and Working Memory (MATRICS) Speed of Processing | The MATRICS is neurocognitive battery designed to assess cognition. Processing speed is a composite score including the following tests: Trail Making Test, BACS: Symbol Coding, Category Fluency: Animal Naming. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. | Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment. | Posted | Mean | Standard Deviation | T- Scores | at 6 months |
|
|
|
|
| Secondary | Change in Cognition and Working Memory (MATRICS) Working Memory | The MATRICS is neurocognitive battery designed to assess cognition. Working Memory score is a composite score based on the following sub-test WMS-III Spatial Span and Letter-Number Span. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. | Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment. | Posted | Mean | Standard Deviation | T- Scores | at 6 months |
|
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|
|
| Secondary | Change in Cognition and Working Memory (MATRICS) Attention and Vigilance | The MATRICS is neurocognitive battery designed to assess cognition. Sustained attention and Vigilance is a composite score based on the Continuous Performance Test -Identical Pairs. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. | Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment. | Posted | Mean | Standard Deviation | T- Scores | at 6 months |
|
|
|
|
| Secondary | Change in Cognition and Working Memory (MATRICS) Verbal Learning | The MATRICS is neurocognitive battery designed to assess cognition. Verbal Learning is a composite score based on the Hopkins Verbal Learning Test-Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. | Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment. | Posted | Mean | Standard Deviation | T- Scores | at 6 months |
|
|
|
|
| Secondary | Change in Cognition and Working Memory (MATRICS) Visual Learning | The MATRICS is neurocognitive battery designed to assess cognition. Visual Learning is a composite score based on the Brief Visuospatial Memory test - Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. | Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment. | Posted | Mean | Standard Deviation | T- Scores | at 6 months |
|
|
|
|
| Secondary | Change in Cognition and Working Memory (MATRICS) Reasoning and Problem Solving | The MATRICS is neurocognitive battery designed to assess cognition. Problem Solving is a composite score based on the NAB Mazes. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population. | Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment. | Posted | Mean | Standard Deviation | T- Scores | at 6 months |
|
|
|
|
| Secondary | Change in Blood Level of Glutathione | Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. The level of glutathione is measured in blood cells. | Posted | Mean | Standard Deviation | mM | at 6 months |
|
|
|
|
| Secondary | Blood Plasma Level of Cysteine | Cysteine is an amino acid, a building block for proteins and is used throughout the body and was measured in blood plasma. | Posted | Mean | Standard Deviation | uM | at 6 months |
|
|
|
|
| Secondary | GPxbc Glutathione Peroxidase Activity in Blood Cells | GPxBC is a measurement of glutathiione peroxidase enzymatic activity in glutathione synthesis and the redox system in blood cells. Measured as umol/min/gHb from blood cells. | Posted | Mean | Standard Deviation | umol/min/gHb | at 6 months |
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| Secondary | Glutamine Brain Level for NAC Group | Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate. | The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site. | Posted | Mean | Standard Deviation | mM | at 6 months |
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| Secondary | Glutamine Brain Level for Placebo Group | Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate. | The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site. | Posted | Mean | Standard Deviation | mM | at 6 months |
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| Secondary | Glutamate Brain Level for NAC Group | Brain marker, glutamate, was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutamate is an excitatory neurotransmitter in the brain. | The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site. | Posted | Mean | Standard Deviation | mM | at 6 months |
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| Secondary | Glutamate Brain Level for Placebo Group | Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate. | The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site. | Posted | Mean | Standard Deviation | mM | at 6 months |
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| Secondary | Glutathione Brain Level for NAC Group | measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. | The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site. | Posted | Mean | Standard Deviation | mM | at 6 months |
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| Secondary | Glutathione Brain Level for Placebo Group | measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. | The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site. | Posted | Mean | Standard Deviation | mM | at 6 months |
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| Secondary | Myo-Inositol Brain Level for the NAC Group | Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate. | The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site. | Posted | Mean | Standard Deviation | mM | at 6 months |
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| Secondary | Myo-Inositol Brain Level for Placebo Group | Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate. | The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site. | Posted | Mean | Standard Deviation | mM | at 6 months |
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| 0 |
| 31 |
| 0 |
| 31 |
| 26 |
| 31 |
| EG001 | Placebo | matching effervescent tablets in water 2 in am and 1 in pm n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM | 0 | 30 | 0 | 30 | 29 | 30 |
| Rigidity | Nervous system disorders | Systematic Assessment |
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| Akathisia | Nervous system disorders | Systematic Assessment |
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| Dry Mouth | Nervous system disorders | Systematic Assessment |
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| Increased Salivation | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Hypotension | Cardiac disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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| Emotional Indifference | Psychiatric disorders | Systematic Assessment |
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| Sedation | Nervous system disorders | Systematic Assessment |
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| Hair Loss | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Immune system disorders | Systematic Assessment |
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Not provided
Not provided
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |