Bipolar DisorderNCT00665444
Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder
A study testing Aripiprazole in people with Bipolar Disorder and Metabolic Syndrome, run by University of Pittsburgh at 1 site in United States.
Trial summary
The proposed study is a non-randomized, open label trial that will examine the potential to reduce metabolic risk factors in patients with bipolar I disorder and improve psychiatric and functional outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Metabolic Syndrome
- What is being tested?
- Aripiprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Aug 2009
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years
- Body mass index (BMI) >=25;
- Currently taking a regimen of medications for bipolar disorder likely to cause, sedation, weight gain or undesirable metabolic effects;
- Able to give basic informed consent
- Meets DSM-IV criteria for lifetime bipolar I or II disorder and are presently in sustained remission (CGI BP<3 in the previous 8-week period measured through a complete psychiatric history at screening and patient report.)
- Epworth Scale Score > 7
- Women of childbearing potential must agree to use a doctor-approved birth control throughout participation in the study
Who cannot join
- Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
- Not competent to provide informed consent in the opinion of the investigator
- Ultra-rapid cycling (>4 episodes per month) bipolar I disorder
- Unstable and severe medical illness that requires immediate and intensive medical attention, When appropriate, the patients can be reconsidered for inclusion in the study if/when their medical condition becomes compatible with participation in a protocol-driven research study
- Women who are planning to become pregnant, currently pregnant, or breast-feeding;
- Current substance dependence; however, if a subject only has substance abuse/use, after the first positive drug screen, another drug screen will be repeated. If that drug screen is positive, the subject will be excluded. If the second drug screen is negative, the subject will be considered for the study;
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- Subjects who have previously failed an adequate trial of aripiprazole.
- Subjects with a suicide attempt in the past 2 years;
- Subjects with a history of inpatient admission in the past 1 year;
- Subjects with a history of homicidal ideation;
- Any subject for whom the PI deems that the potential risks in participating in the study outweigh the potential benefits.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Reducing Medical Risks in Individuals With Bipolar Disorder: Enhancing Outcomes With Aripiprazole
The proposed study is a non-randomized, open label trial that will examine the potential to reduce metabolic risk factors in patients with bipolar I disorder and improve psychiatric and functional outcomes. To accomplish our objective, we plan to conduct a 5-month intervention of 50 obese or overweight adults diagnosed with bipolar disorder. The study will be divided in three steps: Screening, Baseline Period (cross taper to aripiprazole, up to 2 months in duration), Months 1-3 (continued aripiprazole treatment). Subjects will be assessed and meet with their study psychiatrist at least bi-monthly throughout their participation, more frequently when clinically necessary (e.g. during medication tapering or if manic/depressive symptoms emerge). Brief clinical assessments will be conducted at each visit. More thorough assessments will be conducted at Baseline, Week 2, and Month 3.
- Conditions
- Bipolar Disorder, Metabolic Syndrome
- Being tested
- Aripiprazole
- Keywords
- bipolar disorder, sedation, overweight, Abilify, medication
- Medical subject headings
- Bipolar Disorder, Metabolic Syndrome, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify
All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Aripiprazole Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),
Measured: 3 months
Epworth Sleepiness Scale (General Level of Daytime Sleepiness)
Measured: 3 month
Secondary outcomes (4)
Global Assessment of Functioning
Measured: 3 months
Quality of Life Enjoyment Questionnaire
Measured: 3 months
Young Mania Rating Scale
Measured: 3 months
Hamilton Rating Scale for Depression
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: The study was terminated by the sponser due to low study enrollment.
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 of PittsburghThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Holly Swartz, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665444
- Sponsor's protocol ID
- BMS.WPIC.I#0008449
- Status last verified
- Oct 2017
- First submitted
- 21 Apr 2008
- Last updated
- 22 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Medical Risks in Individuals With Bipolar Disorder: Enhancing Outcomes With Aripiprazole
- ClinicalTrials.gov ID
- NCT00665444
- Acronym / sponsor ID
- BMS.WPIC.I#0008449
- Conditions
- Bipolar Disorder, Metabolic Syndrome
- Keywords
- bipolar disorder, sedation, overweight, Abilify, medication
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated by the sponser due to low study enrollment.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Apr 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Posted 12 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a non-randomized, open label trial that will examine the potential to reduce metabolic risk factors in patients with bipolar I disorder and improve psychiatric and functional outcomes. To accomplish our objective, we plan to conduct a 5-month intervention of 50 obese or overweight adults diagnosed with bipolar disorder. The study will be divided in three steps: Screening, Baseline Period (cross taper to aripiprazole, up to 2 months in duration), Months 1-3 (continued aripiprazole treatment). Subjects will be assessed and meet with their study psychiatrist at least bi-monthly throughout their participation, more frequently when clinically necessary (e.g. during medication tapering or if manic/depressive symptoms emerge). Brief clinical assessments will be conducted at each visit. More thorough assessments will be conducted at Baseline, Week 2, and Month 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AripiprazoleAripiprazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 65 years
- Body mass index (BMI) >=25;
- Currently taking a regimen of medications for bipolar disorder likely to cause, sedation, weight gain or undesirable metabolic effects;
- Able to give basic informed consent
- Meets DSM-IV criteria for lifetime bipolar I or II disorder and are presently in sustained remission (CGI BP<3 in the previous 8-week period measured through a complete psychiatric history at screening and patient report.)
Key exclusion criteria (11 listed)
- Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
- Not competent to provide informed consent in the opinion of the investigator
- Ultra-rapid cycling (>4 episodes per month) bipolar I disorder
- Unstable and severe medical illness that requires immediate and intensive medical attention, When appropriate, the patients can be reconsidered for inclusion in the study if/when their medical condition becomes compatible with participation in a protocol-driven research study
- Women who are planning to become pregnant, currently pregnant, or breast-feeding;
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: AbilifyAll subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic. | Drug | A |
Primary outcome
BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),
Time frame: 3 months
Epworth Sleepiness Scale (General Level of Daytime Sleepiness)
Time frame: 3 month
4 secondary outcomes
Global Assessment of Functioning
Time frame: 3 months
Quality of Life Enjoyment Questionnaire
Time frame: 3 months
Young Mania Rating Scale
Time frame: 3 months
Hamilton Rating Scale for Depression
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aripiprazole in people with Bipolar Disorder and Metabolic Syndrome, run by University of Pittsburgh 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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 22 Nov 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2016). 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?
BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns), (time frame: 3 months). 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 22 Nov 2017.