Bipolar DisorderPhase 4NCT00194038
Aripiprazole in Late Life Bipolar Disorder
A Phase 4 study testing Aripiprazole in people with Bipolar Disorder, run by University Hospitals Cleveland Medical Center.
Trial summary
The purpose of this research study is to analyze the effectiveness and tolerability of a new medication, aripiprazole (Abilify), in individuals age 50 years and older who have bipolar disorder (manic-depressive illness). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Aripiprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Jun 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have Bipolar disorder as confirmed by the Mini Neuropsychiatric Interview (MINI)
- Must be age 50 or older
- Must have sub-optimal response to current psychotropic management including at least one of the following:
- Behaviors and symptoms of irritability, agitation, mood liability 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 bipolar disorder
- Intolerance to current psychotropic medications; and
- Must live in the Northeast Ohio area.
Who cannot join
- An unstable medical illness, or a medical illness, which in the opinion of the study investigators, is likely to affect the outcome of the study
- DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months; or
- Receiving carbamazepine.
About this study
The purpose of this research study is to analyze the effectiveness and tolerability of a new medication, aripiprazole (Abilify), in individuals age 50 years and older who have bipolar disorder (manic-depressive illness).
Read the detailed description
While medications such as valproate (Depakote and others) and lithium are generally considered first-line agents in late life bipolar disorder, side effects are common, and many individuals with bipolar disorder continue to have symptoms in spite of medication treatment. A continuing unmet need is the availability of medications that are generally well- tolerated and effective in later life bipolar disorders.
Antipsychotic medications such as Abilify are known to be effective for related conditions such as schizophrenia and are also used by some physicians in clinical settings in combination with mood stabilizing medications (Lithium, Depakote and others) to treat symptoms of bipolar disorder. Currently Abilify is approved by the FDA to treat schizophrenia and to treat bipolar disorder.
- Conditions
- Bipolar Disorder
- Being tested
- Aripiprazole
- Keywords
- Bipolar Disorder, Geriatric Psychiatry, Aripiprazole
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify
Patients were continued on treatment with their existing mood stabilizing medication, and upon enrollment were initiated on aripiprazole augmentation treatment. The initial starting dose of aripiprazole was 5 mg/day, with gradual upward titration as tolerated. Initiation of new additional antipsychotic medications was not permitted during the course of the study, and antipsychotic medications prescribed at study start were tapered and discontinued by week 4 of the study if possible.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure and pulse
Measured: 12 weeks
Weight
Measured: 12 weeks
Abnormal Involuntary Movement Scale (AIMS)
Measured: 12 weeks
Barnes Akathisia Scale (BAS)
Measured: 12 weeks
Simpson Angus Neurological Rating Scale (SAS)
Measured: 12 weeks
Basic serum chemistry - screening and 12/study end
Measured: 12 weeks
Complete blood count (CBC) with differential - screening and 12/study end
Measured: 12 weeks
Electrocardiogram - screening and 12/study end
Measured: 12 weeks
Young Mania Rating Scale (YMRS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
Measured: 12 weeks
Hamilton Depression Rating Scale (HAM-D) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
Measured: 12 weeks
Clinical Global Impression (CGI)
Measured: 12 weeks
Global Assessment Scale (GAS)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Martha Sajatovic, MD, Principal investigator, Case Western Reserve University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194038
- Sponsor's protocol ID
- 10864-01-L0363
- Status last verified
- Jan 2010
- First submitted
- 13 Sep 2005
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sajatovic M, Coconcea N, Ignacio RV, Blow FC, Hays RW, Cassidy KA, Meyer WJ. Aripiprazole therapy in 20 older adults with bipolar disorder: a 12-week, open-label trial. J Clin Psychiatry. 2008 Jan;69(1):41-6. doi: 10.4088/jcp.v69n0106.
PubMed 18312036
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aripiprazole in Late Life Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00194038
- Acronym / sponsor ID
- 10864-01-L0363
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Geriatric Psychiatry, Aripiprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Apr 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to analyze the effectiveness and tolerability of a new medication, aripiprazole (Abilify), in individuals age 50 years and older who have bipolar disorder (manic-depressive illness).
Detailed description
While medications such as valproate (Depakote and others) and lithium are generally considered first-line agents in late life bipolar disorder, side effects are common, and many individuals with bipolar disorder continue to have symptoms in spite of medication treatment. A continuing unmet need is the availability of medications that are generally well- tolerated and effective in later life bipolar disorders.
Antipsychotic medications such as Abilify are known to be effective for related conditions such as schizophrenia and are also used by some physicians in clinical settings in combination with mood stabilizing medications (Lithium, Depakote and others) to treat symptoms of bipolar disorder. Currently Abilify is approved by the FDA to treat schizophrenia and to treat bipolar disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Aripiprazole |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must have Bipolar disorder as confirmed by the Mini Neuropsychiatric Interview (MINI)
- Must be age 50 or older
- Must have sub-optimal response to current psychotropic management including at least one of the following:
- Must live in the Northeast Ohio area.
Key exclusion criteria (3 listed)
- An unstable medical illness, or a medical illness, which in the opinion of the study investigators, is likely to affect the outcome of the study
- DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months; or
- Receiving carbamazepine.
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 |
|---|---|---|
| AripiprazoleAlso: AbilifyPatients were continued on treatment with their existing mood stabilizing medication, and upon enrollment were initiated on aripiprazole augmentation treatment. The initial starting dose of aripiprazole was 5 mg/day, with gradual upward titration as tolerated. Initiation of new additional antipsychotic medications was not permitted during the course of the study, and antipsychotic medications prescribed at study start were tapered and discontinued by week 4 of the study if possible. | Drug | 1 |
Primary outcome
Blood pressure and pulse
Time frame: 12 weeks
Weight
Time frame: 12 weeks
Abnormal Involuntary Movement Scale (AIMS)
Time frame: 12 weeks
Barnes Akathisia Scale (BAS)
Time frame: 12 weeks
Simpson Angus Neurological Rating Scale (SAS)
Time frame: 12 weeks
Basic serum chemistry - screening and 12/study end
Time frame: 12 weeks
Complete blood count (CBC) with differential - screening and 12/study end
Time frame: 12 weeks
Electrocardiogram - screening and 12/study end
Time frame: 12 weeks
Young Mania Rating Scale (YMRS) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
Time frame: 12 weeks
Hamilton Depression Rating Scale (HAM-D) - screening, baseline, and weeks 1, 2, 4, 8, and 12/study end
Time frame: 12 weeks
Clinical Global Impression (CGI)
Time frame: 12 weeks
Global Assessment Scale (GAS)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
- Results publication: PubMed 18312036Sajatovic M, Coconcea N, Ignacio RV, Blow FC, Hays RW, Cassidy KA, Meyer WJ. Aripiprazole therapy in 20 older adults with bipolar disorder: a 12-week, open-label trial. J Clin Psychiatry. 2008 Jan;69(1):41-6. doi: 10.4088/jcp.v69n0106.
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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, MD principal investigator
Case Western Reserve University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole in people with Bipolar Disorder, run by University Hospitals Cleveland Medical Center.
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 7 inclusion and 3 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 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood pressure and pulse (time frame: 12 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00194038, which also lists 1 linked publication.
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 17 Dec 2014.