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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT01460290
Study groupRoleWhat they receive
AsenapineExperimental12-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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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.

  1. First posted26 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

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)
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
Data monitoring committee
Yes

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.

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