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| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
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Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia and schizoaffective disorder, however rates of full or partial non-adherence can exceed 60%. Inadequate adherence is associated with poor outcomes such as relapse, homelessness, hospitalization, and increased health care costs. Studies have shown a direct correlation between non-adherence and rates of relapse in schizophrenia; on average, non-adherent patients have a risk of relapse that is 3.7 times greater than their adherent counterparts. A major obstacle to good outcomes in the maintenance treatment of patients with severe mental illness is difficulty with medication routines on an on-going basis. For this reason, long-acting injectable antipsychotic medication is a particularly attractive treatment option for populations with schizophrenia and schizoaffective disorder, although it is unlikely that medication treatment alone is likely to modify long-term attitudes and behaviors.
This prospective study is a pilot analysis of a combined approach which merges a psychosocial intervention to optimize treatment attitudes towards psychotropic medication (CAE) and long-acting injectable antipsychotic medication (L) in recently homeless individuals with schizophrenia or schizoaffective disorder who are known to have on-going difficulties with treatment non-adherence. It is expected that this combined approach (CAE-L) will improve illness outcomes among the most vulnerable of populations with schizophrenia or schizoaffective disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Noncompliance | Experimental | There was only one arm for this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| haloperidol decanoate | Drug | Drug is in in injectable form and will be administered approximately every four weeks through Week 25 of the study. A participant may continue on the drug after Week 25 at the discretion of his or her treating psychiatrist. Dosage is per package insert or at the discretion of the psychiatrist. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks | Subjects will be asked how many days they have been homeless | Baseline-25 weeks |
| Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks | A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections. | Baseline-25 weeks |
| Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks | Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes. | Baseline-25 weeks |
| Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks | Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes. | Baseline-25 weeks |
| Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks | Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes. | Baseline-25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Health Resource Use Throughout Months 10, 11, and 12 | The frequency of health resource use will be measured through interview of the participant. | Month 1-3, Month 10-12 |
| Change in Serious Mental Illness Severity Score as Measured by the Brief Psychiatric Rating Scale (BPRS) at 25 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martha Sajatovic, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hosptials | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24434094 | Derived | Sajatovic M, Levin J, Ramirez LF, Hahn DY, Tatsuoka C, Bialko CS, Cassidy KA, Fuentes-Casiano E, Williams TD. Prospective trial of customized adherence enhancement plus long-acting injectable antipsychotic medication in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2013 Dec;74(12):1249-55. doi: 10.4088/JCP.12m08331. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Noncompliance | Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE). Dosage form was a long acting injectable administered every three to five weeks. Mean endpoint dose was 68.0 mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Noncompliance | Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE). |
| 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 From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks | Subjects will be asked how many days they have been homeless | 26 participants were asked how many days they were homeless at week 25. Only data for these participants was analyzed for change from baseline to week 25. | Posted | Mean | Standard Deviation | days | Baseline-25 weeks |
|
|
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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 | Patient Noncompliance | Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal EKG | Cardiac disorders | Not due to cardiac condition or study drug, as reviewed by the cardiologist. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martha Sajatovic, Professor of Psychiatry | University Hospitals of Cleveland | 2168442808 | martha.sajatovic@uhhospitals.org |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C033563 | haloperidol decanoate |
| D006220 | Haloperidol |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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|
| haloperidol | Drug | Drug will be administered in oral form to participants not already taking oral haloperidol and then transitioned to the injectable version. Dosage and frequency is at the discretion of the psychiatrist. |
|
| Customized Adherence Enhancement | Behavioral | CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers). |
|
The BPRS, developed by Overall and Gorham (1962), is a widely used, relatively brief scale that measures major psychotic and non-psychotic symptoms in individuals with SMI. The 18-item BPRS is well-validated and is perhaps the most researched instrument in psychiatry. Reliability coefficients are reported to be in the range of 0.56-0.87. Scale Range: 18-126 Lower scores represent improved outcomes. |
| Baseline-25 weeks |
| Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks | Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes. Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse) | Baseline-25 weeks |
| Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 25 Weeks | Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes. | Baseline-25 weeks |
| Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 25 Weeks | Satisfaction will be measured by a seven item inventory taken by the participant. Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35. | 25 weeks |
| Change in Schizophrenia and Schizoaffective Disorder Symptom Severity Scale as Measured by the Positive and Negative Syndrome Scale (PANSS) at 25 Weeks | The PANSS (Kay, Fiszbein, & Opler 1987) was created to assess both the positive and negative symptoms of schizophrenia such as hallucinations and emotional withdrawal, respectively. The scale rates 30 symptoms on a scale from 1 (absent) to 7 (extreme) and has been shown to limit bias between the assessment of positive and negative symptoms, providing a broad but balanced spectrum of the illness. There are three subscales: positive symptoms, negative symptoms, general psychopathology. Potential responses to Items on all subscales range from 1 (absent) to 7 (extreme). Lower scores indicate lower symptoms and, therefore, better outcomes. Higher scores indicate more presence of symptoms and, therefore, worse outcomes. Subscales are combined to produce a total score, which is summed from all of the subscales. Lower total scores indicate lower symptoms and, therefore, better outcomes. Higher total scores indicate more presence of symptoms and, therefore, worse outcomes. | Baseline-25 weeks |
| Frequency of Health Resource Use in the Past 3 Months as Measured at 25 Weeks | The frequency of health resource use will be measured through interview of the participant. | 25 weeks |
| Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 12 Months | Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes. Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse) | 12 months |
| Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 12 Months | Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF. The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes. | Baseline-12 months |
| Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 12 Months | Satisfaction will be measured by a seven item inventory taken by the participant. Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35. | 12 months |
| Days Homeless Out of the Previous 6 Months as Measured at 12 Months | Subjects will be asked how many days they have been homeless | 12 months |
| Treatment Adherence Score as Measured at 12 Months | A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections. | 12 months |
| Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 12 Months | Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes. | 12 months |
| Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 12 Months | Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate better outcomes. | 12 months |
| Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 12 Months | Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes. | 12 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks | A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections. | 17 participants were administered and completed measurement of their Treatment Adherence scores at week 25. Only data for these participants was analyzed for change from baseline to week 25. | Posted | Mean | Standard Deviation | Percentage of doses | Baseline-25 weeks |
|
|
|
| Primary | Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks | Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes. | 15 participants were administered and completed measurement with the DAI at week 25. Only data for these participants was analyzed for change from baseline to week 25. | Posted | Mean | Standard Deviation | units on a scale | Baseline-25 weeks |
|
|
|
| Primary | Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks | Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes. | 16 participants were administered and completed measurement with the Morisky Medication Rating Scale at week 25. Only data for these participants was analyzed for change from baseline to week 25. | Posted | Mean | Standard Deviation | units on a scale | Baseline-25 weeks |
|
|
|
| Primary | Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks | Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes. | 19 participants were administered and completed measurement with the AMQ at week 25. Only data for these participants was analyzed for change from baseline to week 25. Lower scores indicate improved outcomes. | Posted | Mean | Standard Deviation | units on a scale | Baseline-25 weeks |
|
|
|
| Secondary | Frequency of Health Resource Use Throughout Months 10, 11, and 12 | The frequency of health resource use will be measured through interview of the participant. | Three participants were administered and completed this measurement at 12 months. Only data for these participants was analyzed for changes. | Posted | Mean | Standard Deviation | days | Month 1-3, Month 10-12 |
|
|
|
| Secondary | Change in Serious Mental Illness Severity Score as Measured by the Brief Psychiatric Rating Scale (BPRS) at 25 Weeks | The BPRS, developed by Overall and Gorham (1962), is a widely used, relatively brief scale that measures major psychotic and non-psychotic symptoms in individuals with SMI. The 18-item BPRS is well-validated and is perhaps the most researched instrument in psychiatry. Reliability coefficients are reported to be in the range of 0.56-0.87. Scale Range: 18-126 Lower scores represent improved outcomes. | 19 participants were administered and completed measurement with the BPRS at week 25. Only data for these participants was analyzed for change from baseline to week 25. | Posted | Mean | Standard Deviation | units on a scale | Baseline-25 weeks |
|
|
|
| Secondary | Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks | Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes. Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse) | 17 participants were administered and completed measurement with the DAI at week 25. Only data for these participants was analyzed for change at week 25. | Posted | Mean | Standard Deviation | units on a scale | Baseline-25 weeks |
|
|
|
| Secondary | Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 25 Weeks | Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes. | 17 participants were administered and completed measurement with the SOFAS at week 25. Only data for these participants was analyzed for change from baseline to week 25. | Posted | Mean | Standard Deviation | units on a scale | Baseline-25 weeks |
|
|
|
| Secondary | Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 25 Weeks | Satisfaction will be measured by a seven item inventory taken by the participant. Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35. | 17 participants were administered and completed this measure at week 25. | Posted | Mean | Standard Deviation | units on a scale | 25 weeks |
|
|
|
| Secondary | Change in Schizophrenia and Schizoaffective Disorder Symptom Severity Scale as Measured by the Positive and Negative Syndrome Scale (PANSS) at 25 Weeks | The PANSS (Kay, Fiszbein, & Opler 1987) was created to assess both the positive and negative symptoms of schizophrenia such as hallucinations and emotional withdrawal, respectively. The scale rates 30 symptoms on a scale from 1 (absent) to 7 (extreme) and has been shown to limit bias between the assessment of positive and negative symptoms, providing a broad but balanced spectrum of the illness. There are three subscales: positive symptoms, negative symptoms, general psychopathology. Potential responses to Items on all subscales range from 1 (absent) to 7 (extreme). Lower scores indicate lower symptoms and, therefore, better outcomes. Higher scores indicate more presence of symptoms and, therefore, worse outcomes. Subscales are combined to produce a total score, which is summed from all of the subscales. Lower total scores indicate lower symptoms and, therefore, better outcomes. Higher total scores indicate more presence of symptoms and, therefore, worse outcomes. | 19 participants were administered and completed measurement with the PANSS at week 25. Only data for these participants was analyzed for change from baseline to week 25. | Posted | Mean | Standard Deviation | units on a scale | Baseline-25 weeks |
|
|
|
| Secondary | Frequency of Health Resource Use in the Past 3 Months as Measured at 25 Weeks | The frequency of health resource use will be measured through interview of the participant. | 17 participants were administered and completed this measure at week 25. | Posted | Mean | Standard Deviation | days | 25 weeks |
|
|
|
| Secondary | Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 12 Months | Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes. Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse) | 12 participants were administered and completed measurement with the CGI at 12 months. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 12 Months | Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF. The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes. | Six participants were administered and completed measurement with the SOFAS at 12 months. Only data for these participants was analyzed for change from baseline to 12 months. | Posted | Mean | Standard Deviation | units on a scale | Baseline-12 months |
|
|
|
| Secondary | Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 12 Months | Satisfaction will be measured by a seven item inventory taken by the participant. Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35. | Six participants were administered and completed this measure at 12 months. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | Days Homeless Out of the Previous 6 Months as Measured at 12 Months | Subjects will be asked how many days they have been homeless | Six participants were administered and completed this measure at 12 months. | Posted | Mean | Standard Deviation | days | 12 months |
|
|
|
| Secondary | Treatment Adherence Score as Measured at 12 Months | A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections. | Seven participants were administered and completed this measure at 12 months. | Posted | Mean | Standard Deviation | Percentage of doses | 12 months |
|
|
|
| Secondary | Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 12 Months | Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes. | Six participants were administered and completed this measure at 12 months. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 12 Months | Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate better outcomes. | Six participants were administered and completed this measure at 12 months. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 12 Months | Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes. | Seven participants were administered and completed this measure at 12 months. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| 6 |
| 30 |
| 0 |
| 30 |
|
| Stomach Cramps | Gastrointestinal disorders |
|
| High Blood Pressure | Cardiac disorders | Patient was already prescribed blood pressure medication and had not yet started taking study drug at the time of the incident. |
|
| Toothache and Infection | Infections and infestations |
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| Infection in Leg | Infections and infestations |
|
| Complications from Colostomy Surgery | Infections and infestations | Infection from surgery. |
|
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| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
|
| Week 25 - Global Improvement |
|