Bipolar DisorderPhase 4NCT01460290
Asenapine in the Treatment of Older Adults With Bipolar Disorder
A Phase 4 study testing Asenapine in people with Bipolar Disorder, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Asenapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Mar 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Behaviors and symptoms of irritability, agitation, mood lability or diminished ability to interact with others in their place of residence
- Diminished ability to take care of basic personal needs in their place of residence due to symptoms of BD
Who cannot join
- History of intolerance or resistance to asenapine
- Clinical diagnosis of dementia or Mini-mental state (MMSE) < 24
- History of TIA, stroke or MI within the past 12 months
- Medical illness that is the clear, underlying etiology of BD
- Unstable medical illness or condition including prolonged QT interval, which in the opinion of the study investigators, is likely to affect the outcome of the study or the subject's safety
- DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months.
- Rapid cycling BD defined as 4 or more discrete mood episodes within the previous 12 months.
- At high risk for self-harm or suicide
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
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:
Read more
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.
- Conditions
- Bipolar Disorder
- Being tested
- Asenapine
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsenapineDrug
Also called Saphris
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.
| Study group | Role | What they receive |
|---|---|---|
| Asenapine | Experimental | 12-weeks of open-label asenapine treatment Receives: Drug: Asenapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 12 weeks
Secondary outcomes (15)
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.
Measured: Baseline and 12 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University
- Responsible party
- Principal investigator, Martha Sajatovic, University Hospitals Cleveland Medical Center
- Investigators
- Martha Sajatovic, M.D., Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460290
- Sponsor's protocol ID
- 39358
- Status last verified
- Dec 2014
- First submitted
- 24 Oct 2011
- Last updated
- 30 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asenapine in the Treatment of Older Adults With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01460290
- Acronym / sponsor ID
- 39358
- Conditions
- Bipolar Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Case Western Reserve University
- Study start
- Oct 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Posted 5 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asenapine | Experimental | Drug: Asenapine12-weeks of open-label asenapine treatment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (8 listed)
- History of intolerance or resistance to asenapine
- Clinical diagnosis of dementia or Mini-mental state (MMSE) < 24
- History of TIA, stroke or MI within the past 12 months
- Medical illness that is the clear, underlying etiology of BD
- Unstable medical illness or condition including prolonged QT interval, which in the opinion of the study investigators, is likely to affect the outcome of the study or the subject's safety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AsenapineAlso: SaphrisAsenapine 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. | Drug | Asenapine |
Primary outcome
Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D)
Time frame: Baseline and 12 weeks
The minimum possible score is 0 and the maximum score is 52. A higher score implies a worse condition.
Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS)
Time frame: Baseline and 12 weeks
The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
15 secondary outcomes
Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP)
Time frame: Baseline and 12 weeks
Change in Perception of Physical Health as Measured by the Short Form General Health Survey (SF-12)
Time frame: Baseline and 12 weeks
Change in Perception of Mental Health as Measured by the Short Form General Health Survey (SF-12)
Time frame: Baseline and 12 weeks
Change in Depressive Symptoms as Measured by the Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Baseline and 12 weeks
Change in Bipolar Disorder Symptoms as Measured by the Brief Psychiatric Rating Scale (BPRS)
Time frame: Baseline and 12 weeks
Change in Cognitive Status as Measured by the Stroop Task
Time frame: Baseline and 12 weeks
Change in Cognitive Status as Measured by the Trail Making Test
Time frame: Baseline and 12 weeks
Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)
Time frame: Baseline and 12 weeks
Change in Cognitive Status as Measured by the Dementia Rating Scale (DRS)
Time frame: Baseline and 12 weeks
World Health Organization Disability Assessment Scale (WHO-DAS)
Time frame: 12 weeks
Barnes Drug-induced Akathisia Rating Scale (BARS)
Time frame: Baseline and 12 weeks
Assessment of Motor Control Abnormality as Measured by the Simpson Angus Scale (SAS)
Time frame: Baseline and 12 weeks
Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)
Time frame: Baseline and 12 weeks
Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)
Time frame: Baseline and 12 weeks
Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Sajatovic, M.D. principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Asenapine in people with Bipolar Disorder, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D) (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.