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| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
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Objectives: The investigators propose a first-ever, prospective trial of asenapine in older adults with bipolar disorder (BD) to evaluate effects on mood symptoms, tolerability and functional/general health status. Given the dearth of treatment data on older adults with BD, findings are likely to be of substantial clinical interest, may inform larger future studies and will assist in refining bipolar treatment recommendations.
Hypotheses:
Primary: Asenapine therapy will be associated with reduced bipolar manic and depressive symptoms in older adults with BD.
Secondary: Asenapine therapy will be associated with improved functional and general health status, improved global psychopathology, and good tolerability in older adults with BD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asenapine | Experimental | 12-weeks of open-label asenapine treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asenapine | Drug | Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D) | The minimum possible score is 0 and the maximum score is 52. A higher score implies a worse condition. | Baseline and 12 weeks |
| Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS) | The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) | The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition. The CGI-BP has three scores - Mania Severity, Depression Severity, and Overall Bipolar Illness Severity. | Baseline and 12 weeks |
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Inclusion Criteria:
Subjects must have type I Bipolar disorder by DSM-IV criteria confirmed on the Mini Neuropsychiatric Interview (MINI)
Subjects must be age 60 or older
Subjects must have sub-optimal response to current psychotropic management including at least one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martha Sajatovic, M.D. | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Asenapine | 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Asenapine | 12-weeks of open-label asenapine treatment Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg/day and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study. |
| 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 Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D) | The minimum possible score is 0 and the maximum score is 52. A higher score implies a worse condition. | Participants with baseline HAM-D score of 8 or greater were analyzed. Last Observational Carried Forward (LOCF). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 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 | Asenapine | 12-weeks of open-label asenapine treatment Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| emergence of manic symptoms | Psychiatric disorders | Systematic Assessment | Determined to be possibly study related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| elevated liver functions | Hepatobiliary disorders | Systematic Assessment | Resolved with drug discontinuation. Determined to be possibly related to study drug |
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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 |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C522667 | asenapine |
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|
|
| Change in Perception of Physical Health as Measured by the Short Form General Health Survey (SF-12) | The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition. | Baseline and 12 weeks |
| Change in Perception of Mental Health as Measured by the Short Form General Health Survey (SF-12) | The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition. | Baseline and 12 weeks |
| Change in Depressive Symptoms as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) | The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. | Baseline and 12 weeks |
| Change in Bipolar Disorder Symptoms as Measured by the Brief Psychiatric Rating Scale (BPRS) | The minimum possible score is 18 and the maximum score is 126. A higher score implies a worse condition. | Baseline and 12 weeks |
| Change in Cognitive Status as Measured by the Stroop Task | The Stroop evaluates patients for cognitive functioning. Patients are to read words aloud or name colors as quickly as possible in a 45-second period. The measure contains three tasks, each associated with a subscale as follows: Word, Color, and Color-Word. Each subscale contains 100 items. The raw score range for each of the subscales is 0-100. Each raw subscale score is converted to a T-Score. The possible T-Score range for the Word subscale is 15 to 85. The possible T-Score range for the Color subscale is 8 to 92. The possible T-Score range for the Color-Word subscale is 3 to 98. Higher scores on the subscales indicate better cognitive functioning. Subscales are scored independently and are not added to produce a total score. | Baseline and 12 weeks |
| Change in Cognitive Status as Measured by the Trail Making Test | The Trails test is a measure of cognitive functioning. The measure consists of two parts: A and B. In part A, participants are asked to draw a trail connecting a series of numbers in sequential order. In Part B, participants are asked to draw a trail connecting a combination of letters and numbers. The time taken to complete each task is noted as the score (e.g., 78 seconds). For Trails A, there is no upper limit on the score, as subjects are given as much time as is needed for them to complete the task. Higher scores indicate poorer cognitive functioning. In Trails B, the task is timed with an upper limit of five minutes. If, at four minutes, it is determined that the subject will not likely complete the task in the time allotted, then the task can be called off. Higher scores indicate poorer cognitive functioning. | Baseline and 12 weeks |
| Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) | Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-36). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes. Total recall scores appear in this entry below. | Baseline and 12 weeks |
| Change in Cognitive Status as Measured by the Dementia Rating Scale (DRS) | The DRS contains items that evaluate cognitive function across 5 subscales: attention, initiation/perseveration, construction, conceptualization, and memory. Subscale raw score ranges are: attention (0-37), initiation/perseveration (0-37), construction (0-6), conceptualization (0-39), and memory (0-25). Raw subscale scores are added for a total raw score with range 0-144. For each raw subscale score, scaled scores are looked up from a battery of 13 tables. Age of the participant determines which table is to be used. Total raw subscale score also has its own scaled score in the tables. In addition to use in determining scaled scores for each of the subscales, these tables are used to look up the scaled score for the total raw score. The tables are contained in the article Robust and Expanded Norms for the Dementia Rating Scale (Pedraza, Lucas, et al. 2010); Archives of Clinical Neuropsychology 25; 347-358. Higher scores, raw and scaled, indicate better cognitive functioning. | Baseline and 12 weeks |
| World Health Organization Disability Assessment Scale (WHO-DAS) | The WHO-DAS II is used to assess patients for difficulties that they experience due to health conditions. Six subscales are represented which cover the following domains: Getting Around (range 1-10), Self Care (range 1-10), Life Activities (range 1-20), Understand/Communicate (range 1-10), Participation in Society (range 1-10), and Getting Along with People (range 1-10). Lower scores represent more positive outcomes, while higher scores represent worse outcomes. Total summary scores were not computed for our analyses and is optional for the measure. | 12 weeks |
| Barnes Drug-induced Akathisia Rating Scale (BARS) | This scale is used to measure the presence of akathisia, as may result from use of certain psychotropic medications. The scale contains four items and the score for each item is added to produce the total score. Total scores range from 0 to 14. Higher scores indicate more adverse outcomes. | Baseline and 12 weeks |
| Assessment of Motor Control Abnormality as Measured by the Simpson Angus Scale (SAS) | The Simpson-Angus Scale is used to monitor for neurological and musculoskeletal side effects that may be a result of certain psychotropic medications. The scale consists of 10 questions which each can be rated on a scale of 0 to 4. Scores for each item are added to produce a total score. The highest possible total score is 40. Higher scores indicate more adverse outcomes. | Baseline and 12 weeks |
| Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) | Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes. Delayed recall scores appear in this entry below. | Baseline and 12 weeks |
| Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) | Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes. Retention scores appear in this entry below. | Baseline and 12 weeks |
| Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) | Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes. Recognition Discrimination Index appears in this entry below | Baseline and 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS) | The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. | Participants with a baseline YMRS score of 12 or greater were analyzed. LOCF | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) | The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition. The CGI-BP has three scores - Mania Severity, Depression Severity, and Overall Bipolar Illness Severity. | Intention To Treat (ITT) and LOCF | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Perception of Physical Health as Measured by the Short Form General Health Survey (SF-12) | The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition. | ITT and LOCF. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Perception of Mental Health as Measured by the Short Form General Health Survey (SF-12) | The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition. | ITT and LOCF. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Depressive Symptoms as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) | The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. | Participants with a baseline MADRS score of 16 or greater were analyzed. LOCF | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Bipolar Disorder Symptoms as Measured by the Brief Psychiatric Rating Scale (BPRS) | The minimum possible score is 18 and the maximum score is 126. A higher score implies a worse condition. | ITT and LOCF. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Cognitive Status as Measured by the Stroop Task | The Stroop evaluates patients for cognitive functioning. Patients are to read words aloud or name colors as quickly as possible in a 45-second period. The measure contains three tasks, each associated with a subscale as follows: Word, Color, and Color-Word. Each subscale contains 100 items. The raw score range for each of the subscales is 0-100. Each raw subscale score is converted to a T-Score. The possible T-Score range for the Word subscale is 15 to 85. The possible T-Score range for the Color subscale is 8 to 92. The possible T-Score range for the Color-Word subscale is 3 to 98. Higher scores on the subscales indicate better cognitive functioning. Subscales are scored independently and are not added to produce a total score. | Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed. | Posted | Mean | Standard Deviation | T-Score | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Cognitive Status as Measured by the Trail Making Test | The Trails test is a measure of cognitive functioning. The measure consists of two parts: A and B. In part A, participants are asked to draw a trail connecting a series of numbers in sequential order. In Part B, participants are asked to draw a trail connecting a combination of letters and numbers. The time taken to complete each task is noted as the score (e.g., 78 seconds). For Trails A, there is no upper limit on the score, as subjects are given as much time as is needed for them to complete the task. Higher scores indicate poorer cognitive functioning. In Trails B, the task is timed with an upper limit of five minutes. If, at four minutes, it is determined that the subject will not likely complete the task in the time allotted, then the task can be called off. Higher scores indicate poorer cognitive functioning. | Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed. | Posted | Mean | Standard Deviation | seconds | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) | Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-36). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes. Total recall scores appear in this entry below. | Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed. | Posted | Mean | Standard Deviation | correctly recalled items | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Cognitive Status as Measured by the Dementia Rating Scale (DRS) | The DRS contains items that evaluate cognitive function across 5 subscales: attention, initiation/perseveration, construction, conceptualization, and memory. Subscale raw score ranges are: attention (0-37), initiation/perseveration (0-37), construction (0-6), conceptualization (0-39), and memory (0-25). Raw subscale scores are added for a total raw score with range 0-144. For each raw subscale score, scaled scores are looked up from a battery of 13 tables. Age of the participant determines which table is to be used. Total raw subscale score also has its own scaled score in the tables. In addition to use in determining scaled scores for each of the subscales, these tables are used to look up the scaled score for the total raw score. The tables are contained in the article Robust and Expanded Norms for the Dementia Rating Scale (Pedraza, Lucas, et al. 2010); Archives of Clinical Neuropsychology 25; 347-358. Higher scores, raw and scaled, indicate better cognitive functioning. | Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | World Health Organization Disability Assessment Scale (WHO-DAS) | The WHO-DAS II is used to assess patients for difficulties that they experience due to health conditions. Six subscales are represented which cover the following domains: Getting Around (range 1-10), Self Care (range 1-10), Life Activities (range 1-20), Understand/Communicate (range 1-10), Participation in Society (range 1-10), and Getting Along with People (range 1-10). Lower scores represent more positive outcomes, while higher scores represent worse outcomes. Total summary scores were not computed for our analyses and is optional for the measure. | ITT and LOCF. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | Barnes Drug-induced Akathisia Rating Scale (BARS) | This scale is used to measure the presence of akathisia, as may result from use of certain psychotropic medications. The scale contains four items and the score for each item is added to produce the total score. Total scores range from 0 to 14. Higher scores indicate more adverse outcomes. | ITT and LOCF. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Assessment of Motor Control Abnormality as Measured by the Simpson Angus Scale (SAS) | The Simpson-Angus Scale is used to monitor for neurological and musculoskeletal side effects that may be a result of certain psychotropic medications. The scale consists of 10 questions which each can be rated on a scale of 0 to 4. Scores for each item are added to produce a total score. The highest possible total score is 40. Higher scores indicate more adverse outcomes. | ITT and LOCF. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) | Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes. Delayed recall scores appear in this entry below. | Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed. | Posted | Mean | Standard Deviation | correctly recalled items | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) | Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes. Retention scores appear in this entry below. | Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed. | Posted | Mean | Standard Deviation | percentage of items | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) | Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes. Recognition Discrimination Index appears in this entry below | Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed. | Posted | Mean | Standard Deviation | number of items | Baseline and 12 weeks |
|
|
|
| 3 |
| 15 |
| 13 |
| 15 |
|
| recurrence of suicidal ideation | Psychiatric disorders | Systematic Assessment | Occurred in the context of tooth abscess Determined to be not study related |
|
| reported dizziness/refusal to take additional mood stabilizer | Psychiatric disorders | Non-systematic Assessment | occurred after taking a single dose of asenapine in an individual with euphoric mania Determined to be not study related |
|
|
| gastrointestinal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| restlessness | General disorders | Systematic Assessment |
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| tremors | General disorders | Systematic Assessment |
|
| cognitive difficulties | General disorders | Systematic Assessment |
|
| sluggishness/sedation | General disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 12 Week Mania Severity |
|
| Baseline Depression Severity |
|
| 12 Week Depression Severity |
|
| Title | Measurements |
|---|---|
|
| 12 Week Color Subscale |
|
| Baseline Color-Word Subscale |
|
| 12 Week Color-Word Subscale |
|
| Title | Measurements |
|---|---|
|
| 12 Week Trails - Part B |
|
|
| 12 Week WHO-DAS Self Care Subscale |
|
| Baseline WHO-DAS Life Activities Subscale |
|
| 12 Week WHO-DAS Life Activities Subscale |
|
| Baseline WHO-DAS Understand/Communicate Subscale |
|
| 12 Week WHO-DAS Understand/Communicate Subscale |
|
| Baseline WHO-DAS Participation in Society Subscale |
|
| 12 Week WHO-DAS Participation in Society Subscale |
|
| Baseline WHO-DAS Getting Along w/ People Subscale |
|
| 12 Week WHO-DAS Getting Along w/ People Subscale |
|