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This will be a single site safety and proof of concept study conducted at the Indiana University Psychotic Disorders Program. Forty subjects with schizophrenia or schizoaffective disorders will be randomized 1:1 to double-blind treatment with fingolimod or matched placebo for duration of 8 weeks.
Study Design:
This will be a single site safety and proof of concept study conducted at the Indiana University Psychotic Disorders Program. Forty subjects with schizophrenia or schizoaffective disorders will be randomized 1:1 to double-blind treatment with fingolimod or matched placebo for duration of 8 weeks.
All subjects will be admitted to the Indiana Clinical and Translational Sciences Institute Clinical Research Center (CRC) and remain hospitalized for the first 24 (+/- 2) hours post initial dose of study medication. The CRC is located in Indiana University Hospital and has 24 hour staffing with nurses skilled in conducting Phase 1 and Phase 2 investigational drug studies.
Background and Rationale:
Schizophrenia is a severe brain disorder that begins during the teenage years and early twenties and typically progresses to a life-long chronic illness marked by psychotic symptoms, cognitive impairment and poor functioning. A leading hypothesis to account for the symptoms and cognitive dysfunction of this disorder is that abnormalities exist in cortical circuits, particularly in frontal and temporal areas. An interest in cortical circuitry has led to a focus on the integrity of cortical white matter tracts as possibly contributing to the pathophysiology of this illness. Indeed, several lines of evidence have supported abnormalities in white matter structure and function in schizophrenia. Numerous myelin-related genes and their functional expression have been associated with schizophrenia. Moreover, quantitative and qualitative abnormalities in prefrontal cortical oligodendrocytes have been found in postmortem studies. MRI-determined volumetric reductions in prefrontal white matter have been reported in schizophrenia. Advances in MRI technology have enhanced the ability to study white matter pathology in vivo. Diffusion tensor imaging (DTI) and fractional anisotropy (FA) provides an assessment of the density and integrity of white matter tracts. Decreased FA has been reported in many de-myelinating diseases including multiple sclerosis (MS), leukodystrophies, and HIV. Numerous studies using DTI have reported decrements in FA in schizophrenia with the most consistent abnormalities occurring in frontal cortical white matter. Also, FA has been shown to be sensitive to therapeutic drug effects in MS which supports DTI-derived FA as an outcome measure in clinical trials of neuroprotective agents.
Fingolimod (FTY720, approved as Gilenya™ ) is a sphingosine-1-phosphate (S1P) receptor modulator and recently licensed in the USA and several other countries for relapsing forms of multiple sclerosis (MS). It is administered as a once per day oral preparation. In registration clinical trials, it had positive effects on brain atrophy, MRI-determined axonal lesions and relapse rates. Significant improvement in the mean number of MRI assessed T1 gadolinium (Gd) enhanced lesions/patient and the percentage of patients free of T1 Gd-enhanced lesions was observed within 6 months of treatment and there was evidence of clinical improvement as early as 2 months after treatment initiation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fingolimod | Active Comparator | 0.5mg of fingolimod, oral administration, daily, for 8 weeks. |
|
| placebo | Placebo Comparator | placebo, oral administration, daily, for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingolimod | Drug | 0.5mg each day of 8 week cycle |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| QTcB Change | To determine the safety of fingolimod, as measured by the electrocardiogram (ECG) QT interval corrected by Bazett's (QTcB) value. | Screening, Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 84, Day 112 |
| Levels of Lymphocyte | To determine the safety of fingolimod, as measured by the absolute lymphocyte count | Baseline, 4 weeks, 8 weeks |
| Symptom Changes - PANSS Total Score | The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms. | Baseline, 4 weeks, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Memory - BACS | The Brief Assessment of Cognition in Schizophrenia (BACS) is a battery specifically designed to measure treatment-related changes in cognition. The BACS utilizes 6 tasks, and has alternate forms, thus minimizing practice effects. Each task generates a raw score (with a higher score indicating better performance): verbal memory 0-75; digit sequencing 0-28; token motor task 0-100; semantic&letter fluency 0-148; symbol coding 0-110; and tower of London 0-22. The raw scores are used to generate a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance. |
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Inclusion
18 to 65 yrs, able to give informed consent
DSM IV-TR Diagnosis of schizophrenia or schizoaffective disorder
Previous and/or current exposure to one of the following antipsychotic medications (clozapine, olanzapine, risperidone, paliperidone, haloperidol, quetiapine) as defined by a minimum of 8 weeks in duration greater than or equal to the Food and Drug Administration (FDA) approved therapeutic range for schizophrenia at the time of study entry OR previous and/or current exposure to two antipsychotic medications as defined by a minimum of 4 weeks in duration and greater than or equal to the FDA approved therapeutic range for schizophrenia at the time of study entry
willing to participate in a minimum of 1 day of hospitalization
Clinical stability:
Female subjects of childbearing potential must test negative for pregnancy at screening and agree to use a single, effective, medically acceptable method of birth control for the duration of the study and for two months following cessation of study medication
Subjects must agree not to consume tonic water for the duration of the study and for two months following cessation of study medication
Sub-optimally treated positive OR negative symptoms as defined by the Brief Psychiatric Rating Scale (BPRS):
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Alan Breier, MD | Indiana University | Principal Investigator |
| Michael Francis, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for NeuroImaging | Indianapolis | Indiana | 46202 | United States | ||
| Prevention and Recovery Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fingolimod | 0.5mg of fingolimod, oral administration, daily, for 8 weeks. Fingolimod: 0.5mg each day of 8 week cycle |
| FG001 | Placebo | placebo, oral administration, daily, for 8 weeks. placebo: 1 tablet each day of 8 week cycle |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fingolimod | 0.5mg of fingolimod, oral administration, daily, for 8 weeks. Fingolimod: 0.5mg each day of 8 week cycle |
| BG001 | Placebo | placebo, oral administration, daily, for 8 weeks. placebo: 1 tablet each day of 8 week cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | QTcB Change | To determine the safety of fingolimod, as measured by the electrocardiogram (ECG) QT interval corrected by Bazett's (QTcB) value. | Posted | Mean | Standard Deviation | ms | Screening, Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 84, Day 112 |
|
Screening through day 112
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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 | Fingolimod | 0.5mg of fingolimod, oral administration, daily, for 8 weeks. Fingolimod: 0.5mg each day of 8 week cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for exacerbation of schizophrenia | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asymptomatic Bradycardia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alan Breier | Indiana University | 317-880-8495 | abreier@iupui.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2016 | Mar 20, 2019 | Prot_SAP_000.pdf |
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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 |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| placebo | Drug | 1 tablet each day of 8 week cycle |
|
|
| Baseline, 4 weeks, 8 weeks |
| Cognition Change - BACS | The Brief Assessment of Cognition in Schizophrenia (BACS) is a battery specifically designed to measure treatment-related changes in cognition by utilizing 6 tasks, and has alternate forms, thus minimizing practice effects. Each task generates a raw score (with a higher score indicating better performance): verbal memory 0-75; digit sequencing 0-28; token motor task 0-100; semantic&letter fluency 0-148; symbol coding 0-110; and tower of London 0-22. The raw scores are used to generate a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance. | Baseline, 4 weeks, 8 weeks |
| Cognition Change - Trails B | The Trail Making Test-Part B (Trails B) is a measure of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive targets on a sheet of paper. In Part B version the subject alternates between numbers and letters (1, A, 2, B, etc.) The goal of the test is for the subject is to finish part B as quickly as possible, the time taken to complete the test is used as the primary performance metric. The score is the number of seconds it took to complete the test. | Baseline, 4 weeks, 8 weeks |
| Positive Symptom Change - PANSS | The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms. | Baseline, 4 weeks, 8 weeks |
| Negative Symptom Change - PANSS | The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms. | Baseline, 4 weeks, 8 weeks |
| Plasma Cytokines Levels - IL-10 | To assess IL-10 plasma cytokines levels changes in participants taking fingolimod versus placebo | Baseline, 4 weeks, 8 weeks |
| Plasma Cytokines Levels - IL-17A | To assess IL-17A plasma cytokines levels changes in participants taking fingolimod versus placebo | Baseline, 4 weeks, 8 weeks |
| Plasma Cytokines Levels - IL-1BETA | To assess IL-1BETA plasma cytokines levels changes in participants taking fingolimod versus placebo | Baseline, 4 weeks, 8 weeks |
| Plasma Cytokines Levels - IL-2 | To assess IL-2 plasma cytokines levels changes in participants taking fingolimod versus placebo | Baseline, 4 weeks, 8 weeks |
| Plasma Cytokines Levels - IL-4 | To assess IL-4 plasma cytokines levels changes in participants taking fingolimod versus placebo | Baseline, 4 weeks, 8 weeks |
| Plasma Cytokines Levels - IL-6 | To assess IL-6 plasma cytokines levels changes in participants taking fingolimod versus placebo | Baseline, 4 weeks, 8 weeks |
| Plasma Cytokines Levels - IL-8 | To assess IL-8 plasma cytokines levels changes in participants taking fingolimod versus placebo | Baseline, 4 weeks, 8 weeks |
| Plasma Cytokines Levels - TNFa | To assess TNFa plasma cytokines levels changes in participants taking fingolimod versus placebo | Baseline, 4 weeks, 8 weeks |
| Plasma Cytokines Levels - IFNgamma | To assess IFNgamma plasma cytokines levels changes in participants taking fingolimod versus placebo | Baseline, 4 weeks, 8 weeks |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Larue D Carter Memorial Hospital | Indianapolis | Indiana | 46222 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Levels of Lymphocyte | To determine the safety of fingolimod, as measured by the absolute lymphocyte count | Posted | Mean | Standard Deviation | 10^3 lymphocytes/uL | Baseline, 4 weeks, 8 weeks |
|
|
|
| Primary | Symptom Changes - PANSS Total Score | The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 8 weeks |
|
|
|
| Secondary | Verbal Memory - BACS | The Brief Assessment of Cognition in Schizophrenia (BACS) is a battery specifically designed to measure treatment-related changes in cognition. The BACS utilizes 6 tasks, and has alternate forms, thus minimizing practice effects. Each task generates a raw score (with a higher score indicating better performance): verbal memory 0-75; digit sequencing 0-28; token motor task 0-100; semantic&letter fluency 0-148; symbol coding 0-110; and tower of London 0-22. The raw scores are used to generate a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 8 weeks |
|
|
|
| Secondary | Cognition Change - BACS | The Brief Assessment of Cognition in Schizophrenia (BACS) is a battery specifically designed to measure treatment-related changes in cognition by utilizing 6 tasks, and has alternate forms, thus minimizing practice effects. Each task generates a raw score (with a higher score indicating better performance): verbal memory 0-75; digit sequencing 0-28; token motor task 0-100; semantic&letter fluency 0-148; symbol coding 0-110; and tower of London 0-22. The raw scores are used to generate a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 8 weeks |
|
|
|
| Secondary | Cognition Change - Trails B | The Trail Making Test-Part B (Trails B) is a measure of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive targets on a sheet of paper. In Part B version the subject alternates between numbers and letters (1, A, 2, B, etc.) The goal of the test is for the subject is to finish part B as quickly as possible, the time taken to complete the test is used as the primary performance metric. The score is the number of seconds it took to complete the test. | Posted | Mean | Standard Deviation | seconds | Baseline, 4 weeks, 8 weeks |
|
|
|
| Secondary | Positive Symptom Change - PANSS | The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 8 weeks |
|
|
|
| Secondary | Negative Symptom Change - PANSS | The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 8 weeks |
|
|
|
| Secondary | Plasma Cytokines Levels - IL-10 | To assess IL-10 plasma cytokines levels changes in participants taking fingolimod versus placebo | Posted | Mean | Standard Deviation | pg/ml | Baseline, 4 weeks, 8 weeks |
|
|
|
| Secondary | Plasma Cytokines Levels - IL-17A | To assess IL-17A plasma cytokines levels changes in participants taking fingolimod versus placebo | Posted | Mean | Standard Deviation | pg/ml | Baseline, 4 weeks, 8 weeks |
|
|
|
| Secondary | Plasma Cytokines Levels - IL-1BETA | To assess IL-1BETA plasma cytokines levels changes in participants taking fingolimod versus placebo | Posted | Mean | Standard Deviation | pg/ml | Baseline, 4 weeks, 8 weeks |
|
|
|
| Secondary | Plasma Cytokines Levels - IL-2 | To assess IL-2 plasma cytokines levels changes in participants taking fingolimod versus placebo | Posted | Mean | Standard Deviation | pg/ml | Baseline, 4 weeks, 8 weeks |
|
|
|
| Secondary | Plasma Cytokines Levels - IL-4 | To assess IL-4 plasma cytokines levels changes in participants taking fingolimod versus placebo | Posted | Mean | Standard Deviation | pg/ml | Baseline, 4 weeks, 8 weeks |
|
|
|
| Secondary | Plasma Cytokines Levels - IL-6 | To assess IL-6 plasma cytokines levels changes in participants taking fingolimod versus placebo | Posted | Mean | Standard Deviation | pg/ml | Baseline, 4 weeks, 8 weeks |
|
|
|
| Secondary | Plasma Cytokines Levels - IL-8 | To assess IL-8 plasma cytokines levels changes in participants taking fingolimod versus placebo | Posted | Mean | Standard Deviation | pg/ml | Baseline, 4 weeks, 8 weeks |
|
|
|
| Secondary | Plasma Cytokines Levels - TNFa | To assess TNFa plasma cytokines levels changes in participants taking fingolimod versus placebo | Posted | Mean | Standard Deviation | pg/ml | Baseline, 4 weeks, 8 weeks |
|
|
|
| Secondary | Plasma Cytokines Levels - IFNgamma | To assess IFNgamma plasma cytokines levels changes in participants taking fingolimod versus placebo | Posted | Mean | Standard Deviation | pg/ml | Baseline, 4 weeks, 8 weeks |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 18 |
| 18 |
| EG001 | Placebo | placebo, oral administration, daily, for 8 weeks. placebo: 1 tablet each day of 8 week cycle | 0 | 22 | 2 | 22 | 13 | 22 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hyponatremia | Blood and lymphatic system disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| headache | General disorders | Systematic Assessment |
|
| Low back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| QTc Interval Prolongation | Cardiac disorders | Systematic Assessment |
|
| Mobitz I AV Block | Cardiac disorders | Systematic Assessment |
|
| Sinus Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Hypertension, intermittent | Cardiac disorders | Systematic Assessment |
|
| Lymphocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Elevated Liver Enzymes | Hepatobiliary disorders | Systematic Assessment |
|
| Blurry vision | Eye disorders | Systematic Assessment |
|
| Dry mouth | General disorders | Systematic Assessment |
|
| Exacerbation of Allergic Rhinitis | General disorders | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| mood lability | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Increased auditory hallucinations | Psychiatric disorders | Systematic Assessment |
|
| Paresthesia | General disorders | Systematic Assessment |
|
| Stuttering | General disorders | Systematic Assessment |
|
| Dyskinetic Movement | General disorders | Systematic Assessment |
|
| Worsening of intermittent panic attacks | Psychiatric disorders | Systematic Assessment |
|
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| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
| D002241 | Carbohydrates |
| Absolute lymphocyte count - 8 weeks |
|
| PANSS Total Score - 8 weeks |
|
| BACS Verbal Memory - 8 weeks |
|
| BACS Composite Score - 8 weeks |
|
| Trails B - 8 weeks |
|
| PANSS Positive Score - 8 weeks |
|
| PANSS Negative Score - 8 weeks |
|
| IL10 - 8 weeks |
|
| IL17A - 8 weeks |
|
| IL1BETA - 8 weeks |
|
| IL2 - 8 weeks |
|
| IL4 - 8 weeks |
|
| IL6 - 8 weeks |
|
| IL8 - 8 weeks |
|
| TNFa - 8 weeks |
|
| IFNgamma - 8 weeks |
|