Trial · NCT01460290
Asenapine in the Treatment of Older Adults With Bipolar Disorder
NCT01460290, Phase 4, Completed, University Hospitals Cleveland Medical Center; results first posted 2014-08-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Asenapine in the Treatment of Older Adults With Bipolar Disorder. Trials, record NCT01460290. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01460290
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Asenapine in the Treatment of Older Adults With Bipolar Disorder
- NCT number
- NCT01460290
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 15 participants, actual
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Conditions
- Bipolar Disorder
- Interventions
- Asenapine
- First posted
- 2011-10-26
- Last updated
- 2014-12-30
- Results first posted
- 2014-08-05
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D) | Baseline and 12 weeks | The minimum possible score is 0 and the maximum score is 52. A higher score implies a worse condition. |
| Primary | Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS) | Baseline and 12 weeks | The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. |
| Secondary | Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) | Baseline and 12 weeks | 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. |
| Secondary | Change in Perception of Physical Health as Measured by the Short Form General Health Survey (SF-12) | Baseline and 12 weeks | The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition. |
| Secondary | Change in Perception of Mental Health as Measured by the Short Form General Health Survey (SF-12) | Baseline and 12 weeks | The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition. |
| Secondary | Change in Depressive Symptoms as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) | Baseline and 12 weeks | The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition. |
| Secondary | Change in Bipolar Disorder Symptoms as Measured by the Brief Psychiatric Rating Scale (BPRS) | Baseline and 12 weeks | The minimum possible score is 18 and the maximum score is 126. A higher score implies a worse condition. |
| Secondary | Change in Cognitive Status as Measured by the Stroop Task | Baseline and 12 weeks | 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. |
| Secondary | Change in Cognitive Status as Measured by the Trail Making Test | Baseline and 12 weeks | 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. |
| Secondary | Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) | Baseline and 12 weeks | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D) | Baseline and 12 weeks | Participants with baseline HAM-D score of 8 or greater were analyzed. Last Observational Carried Forward (LOCF). | units on a scale | MEAN |
| PRIMARY | Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS) | Baseline and 12 weeks | Participants with a baseline YMRS score of 12 or greater were analyzed. LOCF | units on a scale | MEAN |
| SECONDARY | Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) | Baseline and 12 weeks | Intention To Treat (ITT) and LOCF | units on a scale | MEAN |
| SECONDARY | Change in Perception of Physical Health as Measured by the Short Form General Health Survey (SF-12) | Baseline and 12 weeks | ITT and LOCF. | units on a scale | MEAN |
| SECONDARY | Change in Perception of Mental Health as Measured by the Short Form General Health Survey (SF-12) | Baseline and 12 weeks | ITT and LOCF. | units on a scale | MEAN |
| SECONDARY | Change in Depressive Symptoms as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) | Baseline and 12 weeks | Participants with a baseline MADRS score of 16 or greater were analyzed. LOCF | units on a scale | MEAN |
| SECONDARY | Change in Bipolar Disorder Symptoms as Measured by the Brief Psychiatric Rating Scale (BPRS) | Baseline and 12 weeks | ITT and LOCF. | units on a scale | MEAN |
| SECONDARY | Change in Cognitive Status as Measured by the Stroop Task | Baseline and 12 weeks | Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed. | T-Score | MEAN |
| SECONDARY | Change in Cognitive Status as Measured by the Trail Making Test | Baseline and 12 weeks | Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed. | seconds | MEAN |
| SECONDARY | Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) | Baseline and 12 weeks | Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed. | correctly recalled items | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D) | Asenapine | Baseline HAM-D | 17.5 | Standard Deviation 4.8 | units on a scale |
| Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D) | Asenapine | 12 Week HAM-D | 10.3 | Standard Deviation 6.3 | units on a scale |
| Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS) | Asenapine | Baseline YMRS | 27.9 | Standard Deviation 4.4 | units on a scale |
| Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS) | Asenapine | 12 Week YMRS | 18.1 | Standard Deviation 14.2 | units on a scale |
| Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) | Asenapine | Baseline Overall Severity | 4.4 | Standard Deviation 1.0 | units on a scale |
| Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) | Asenapine | 12 Week Overall Severity | 2.2 | Standard Deviation 1.0 | units on a scale |
| Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) | Asenapine | Baseline Mania Severity | 2.7 | Standard Deviation 1.7 | units on a scale |
| Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) | Asenapine | 12 Week Mania Severity | 1.9 | Standard Deviation 1.1 | units on a scale |
| Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) | Asenapine | Baseline Depression Severity | 3.6 | Standard Deviation 1.5 | units on a scale |
| Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) | Asenapine | 12 Week Depression Severity | 1.7 | Standard Deviation 0.7 | units on a scale |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Asenapine | 15 | |
| Overall Study | COMPLETED | Asenapine | 11 | |
| Overall Study | NOT COMPLETED | Asenapine | 4 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | elevated liver functions | Hepatobiliary disorders | Asenapine | 1 | 15 | 1 |
| other | gastrointestinal discomfort | Gastrointestinal disorders | Asenapine | 5 | 15 | 5 |
| other | restlessness | General disorders | Asenapine | 2 | 15 | 2 |
| other | tremors | General disorders | Asenapine | 2 | 15 | 2 |
| other | cognitive difficulties | General disorders | Asenapine | 2 | 15 | 2 |
| other | sluggishness/sedation | General disorders | Asenapine | 2 | 15 | 2 |
| serious | emergence of manic symptoms | Psychiatric disorders | Asenapine | 1 | 15 | 1 |
| serious | recurrence of suicidal ideation | Psychiatric disorders | Asenapine | 1 | 15 | 1 |
| serious | reported dizziness/refusal to take additional mood stabilizer | Psychiatric disorders | Asenapine | 1 | 15 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Asenapine | ||
| Total, other adverse events | Asenapine | 13 | 15 |
| Total, serious adverse events | Asenapine | 3 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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