Bipolar DisorderPhase 4NCT00181779
Aripiprazole for the Treatment of Mania in Children and Adolescents With Bipolar Disorder
A Phase 4 study testing aripiprazole (Abilify) in people with Bipolar Disorder and Mania, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is an open-labeled study of Aripiprazole, testing its efficacy in the treatment of mania in children and adolescents with Bipolar I, Bipolar II and Bipolar Spectrum Disorder over 8 weeks. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Bipolar Disorder, Mania
- What is being tested?
- aripiprazole (Abilify)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Dec 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients, 6-17 years of age.
- Patient and parent must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- Patients and their legal representative must be considered reliable.
- Each patient and his/her authorized legal representative must understand the nature of the study. The patient's authorized legal representative must sign an informed consent document and the patient must sign an informed assent document.
- Patient must have a diagnosis of bipolar I or bipolar II disorder and currently display an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders). Eligible will also be children with bipolar spectrum disorder (or sub-threshold bipolar disorder) operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but meet fewer elements in criteria B (only require 2 items for elation category and 3 for irritability).
- Patients must have an initial score on the Y-MRS total score of at least 15.
- Patient must be able to participate in mandatory blood draws.
- Patient must be able to swallow pills.
Who cannot join
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- Serious, unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- Uncorrected hypothyroidism or hyperthyroidism.
- History of severe allergies or multiple adverse drug reactions.
- Non-febrile seizures without a clear and resolved etiology.
- Leukopenia or history of leukopenia without a clear and resolved etiology.
Show all 13Show fewer
- DSM-IV substance (except nicotine or caffeine) dependence within past 6 months.
- Judged clinically to be at serious suicidal risk.
- Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol.
- History of intolerance or a non-responder to Aripiprazole as determined by the clinician.
- Treatment with nonreversible monoamine oxidase inhibitors within 2 weeks prior to Visit 2.
- Current diagnosis of schizophrenia.
- For concomitant stimulant therapy used to treat ADHD, patients must have been on a stable dose of the medication for 1 month prior to randomization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Cambridge, Massachusetts, 02138
About this study
Official title: Open-Label Pilot Study of Aripiprazole for the Treatment of Mania in Children and Adolescents With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder
This is an open-labeled study of Aripiprazole, testing its efficacy in the treatment of mania in children and adolescents with Bipolar I, Bipolar II and Bipolar Spectrum Disorder over 8 weeks. This is an exploratory, pilot study, seeking to determine whether Aripiprazole is efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum disorder. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Read the detailed description
Initial clinical evidence suggests that atypical neuroleptics may play a unique therapeutic role in the management of pediatric bipolar disorder. Aripiprazole is a novel neuroleptic recently approved by the FDA for the treatment of schizophrenia, and it has a unique pharmacological profile believed to be fundamentally different from other available antipsychotics. Many previous studies have reported increased efficacy of Aripiprazole compared to placebo. Unfortunately, Aripiprazole has not been investigated in children and adolescents, and as such, safety and efficacy has not been established for these populations.
This is an exploratory, pilot study, seeking to determine whether Aripiprazole is efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum disorder. The study results, gathered from an 8 week open-label treatment period and subsequent 10 month extension period, will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
- Conditions
- Bipolar Disorder, Mania
- Being tested
- aripiprazole (Abilify)
- Keywords
- mania, Abilify, children, bipolar disorder
- Medical subject headings
- Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazole (Abilify)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on the Young Mania Rating Scales
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionDec 2006
- Study completionDec 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.
- More trials run by Massachusetts General HospitalThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Joseph Biederman, MD, Massachusetts General Hospital
- Investigators
- Joseph Biederman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181779
- Sponsor's protocol ID
- 2003-P-000153
- Status last verified
- Oct 2013
- First submitted
- 13 Sep 2005
- Last updated
- 22 Oct 2013
- Results posted
- No
Publications
Biederman J, Mick E, Spencer T, Doyle R, Joshi G, Hammerness P, Kotarski M, Aleardi M, Wozniak J. An open-label trial of aripiprazole monotherapy in children and adolescents with bipolar disorder. CNS Spectr. 2007 Sep;12(9):683-9. doi: 10.1017/s1092852900021519.
PubMed 17805214
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Pilot Study of Aripiprazole for the Treatment of Mania in Children and Adolescents With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder
- ClinicalTrials.gov ID
- NCT00181779
- Acronym / sponsor ID
- 2003-P-000153
- Conditions
- Bipolar Disorder, Mania
- Keywords
- mania, Abilify, children, bipolar disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Feb 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 16 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.
This is an open-labeled study of Aripiprazole, testing its efficacy in the treatment of mania in children and adolescents with Bipolar I, Bipolar II and Bipolar Spectrum Disorder over 8 weeks. This is an exploratory, pilot study, seeking to determine whether Aripiprazole is efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum disorder. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Detailed description
Initial clinical evidence suggests that atypical neuroleptics may play a unique therapeutic role in the management of pediatric bipolar disorder. Aripiprazole is a novel neuroleptic recently approved by the FDA for the treatment of schizophrenia, and it has a unique pharmacological profile believed to be fundamentally different from other available antipsychotics. Many previous studies have reported increased efficacy of Aripiprazole compared to placebo. Unfortunately, Aripiprazole has not been investigated in children and adolescents, and as such, safety and efficacy has not been established for these populations.
This is an exploratory, pilot study, seeking to determine whether Aripiprazole is efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum disorder. The study results, gathered from an 8 week open-label treatment period and subsequent 10 month extension period, will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male or female patients, 6-17 years of age.
- Patient and parent must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- Patients and their legal representative must be considered reliable.
- Each patient and his/her authorized legal representative must understand the nature of the study. The patient's authorized legal representative must sign an informed consent document and the patient must sign an informed assent document.
- Patient must have a diagnosis of bipolar I or bipolar II disorder and currently display an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders). Eligible will also be children with bipolar spectrum disorder (or sub-threshold bipolar disorder) operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but meet fewer elements in criteria B (only require 2 items for elation category and 3 for irritability).
Key exclusion criteria (13 listed)
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- Serious, unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- Uncorrected hypothyroidism or hyperthyroidism.
- History of severe allergies or multiple adverse drug reactions.
- Non-febrile seizures without a clear and resolved etiology.
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 |
|---|---|---|
| aripiprazole (Abilify) | Drug | – |
Primary outcome
Scores on the Young Mania Rating Scales
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 22 Oct 2013.
- Derived from this study: PubMed 17805214Biederman J, Mick E, Spencer T, Doyle R, Joshi G, Hammerness P, Kotarski M, Aleardi M, Wozniak J. An open-label trial of aripiprazole monotherapy in children and adolescents with bipolar disorder. CNS Spectr. 2007 Sep;12(9):683-9. doi: 10.1017/s1092852900021519.
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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.
Joseph Biederman, MD principal investigator
Massachusetts General Hospital
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 aripiprazole (Abilify) in people with Bipolar Disorder and Mania, run by Massachusetts General Hospital 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 8 inclusion and 13 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 22 Oct 2013. 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?
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?
Scores on the Young Mania Rating Scales. 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 NCT00181779, 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 22 Oct 2013.