Bipolar DisorderPhase 3NCT00221416
An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder
A Phase 3 study testing Aripiprazole in people with Bipolar Disorder, run by University of Cincinnati.
Trial summary
This is an investigator-initiated study whose primary aim is to determine the effectiveness of aripiprazole (Abilify®) in helping persons with symptoms of mania whose current medications do not completely control those symptoms. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Aripiprazole
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Dec 2008
- Phase
- Phase 3
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or Females; between the ages of 7 years 0 months to 17 years 12 months
- Bipolar I Disorder, mixed or manic episode, psychotic or non-psychotic, according to DSM IV criteria.
- Score of > 20 on the Y-MRS at baseline.
- Ability and willingness to provide assent and informed written consent from at least one parent or legal guardian
- No current general medical illnesses requiring medication that would effect interpretation of study outcomes.
- Subjects must have at least normal intelligence.
- Female patients of childbearing potential must be using a reliable method of contraception, e.g. hormonal contraceptives, Depo-Provera, double-barrier methods (e.g. condom and diaphragm, condom and foam, condom and sponge) or abstinence). Females of childbearing potential must have a negative serum pregnancy test immediately prior to study entry.
- Must be able to swallow oral medication (tablets).
Who cannot join
- A current or lifetime DSM-IV diagnosis of schizophrenia, autistic disorder, schizoaffective disorder, pervasive developmental disorder, or obsessive compulsive disorder
- Known IQ < 70
- Patients with high suicide risk defined as any serious suicide attempt that required medical intervention or current suicide risk that cannot be safely managed as determined by the clinical judgment of the investigator.
- Concurrent cognitive behavioral psychotherapy.
- Present or past (within 3 months) DSM-IV diagnosis of substance abuse/dependence.
- Female patients who are pregnant, trying to become pregnant, nursing an infant, or not using a reliable form of contraception.
Show all 12Show fewer
- Bipolar subjects who are currently stable on mood stabilizers or atypical neuroleptics.
- Patient has failed on a previous adequate course of aripiprazole.
- A known hypersensitivity to aripiprazole or to any of its components.
- Participated in an investigational drug/device trial within the last 30 days.
- Patients with severe renal insufficiency, defined as creatinine clearance <30ml/min. by history or by lab findings.
- -
About this study
This is an investigator-initiated study whose primary aim is to determine the effectiveness of aripiprazole (Abilify®) in helping persons with symptoms of mania whose current medications do not completely control those symptoms. Aripiprazole is a medication that has been approved by the United States Food and Drug Administration (FDA) for the treatment of Schizophrenia.
A secondary aim of this research is to explore whether CYP 2D6 polymorphisms are related to side effects with aripiprazole. The goal of this research is to identify individuals who metabolize aripiprazole more rapidly or slowly, which will potentially help the clinician make dosing adjustments and decrease the risk of adverse events.
Read the detailed description
The primary aim of this study is to assess the effectiveness, safety, and tolerability of aripiprazole for the treatment of children and adolescents with bipolar disorder. The secondary aim of this study is to determine if common polymorphic variations in the CYP 2D6 gene underlie the inter-individual variability in aripiprazole systemic drug exposure and the occurrence of treatment emergent side effects.
- Conditions
- Bipolar Disorder
- Being tested
- Aripiprazole
- Keywords
- child, adolescent
- 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
5-20 mg/day
What is being measured
The primary outcome is the main question the study is designed to answer.
YMRS & CGI
Measured: 6 weeks
Secondary outcomes (1)
OAS CDRS-R
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Kowatch, Nationwide Children's Hospital
- Investigators
- Robert A Kowatch, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221416
- Sponsor's protocol ID
- 04-7-11
- Status last verified
- Jun 2013
- First submitted
- 14 Sep 2005
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00221416
- Acronym / sponsor ID
- 04-7-11
- Conditions
- Bipolar Disorder
- Keywords
- child, adolescent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Bristol-Myers Squibb
- Study start
- Jun 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 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 investigator-initiated study whose primary aim is to determine the effectiveness of aripiprazole (Abilify®) in helping persons with symptoms of mania whose current medications do not completely control those symptoms. Aripiprazole is a medication that has been approved by the United States Food and Drug Administration (FDA) for the treatment of Schizophrenia.
A secondary aim of this research is to explore whether CYP 2D6 polymorphisms are related to side effects with aripiprazole. The goal of this research is to identify individuals who metabolize aripiprazole more rapidly or slowly, which will potentially help the clinician make dosing adjustments and decrease the risk of adverse events.
Detailed description
The primary aim of this study is to assess the effectiveness, safety, and tolerability of aripiprazole for the treatment of children and adolescents with bipolar disorder. The secondary aim of this study is to determine if common polymorphic variations in the CYP 2D6 gene underlie the inter-individual variability in aripiprazole systemic drug exposure and the occurrence of treatment emergent side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Male or Females; between the ages of 7 years 0 months to 17 years 12 months
- Bipolar I Disorder, mixed or manic episode, psychotic or non-psychotic, according to DSM IV criteria.
- Score of > 20 on the Y-MRS at baseline.
- Ability and willingness to provide assent and informed written consent from at least one parent or legal guardian
- No current general medical illnesses requiring medication that would effect interpretation of study outcomes.
Key exclusion criteria (12 listed)
- A current or lifetime DSM-IV diagnosis of schizophrenia, autistic disorder, schizoaffective disorder, pervasive developmental disorder, or obsessive compulsive disorder
- Known IQ < 70
- Patients with high suicide risk defined as any serious suicide attempt that required medical intervention or current suicide risk that cannot be safely managed as determined by the clinical judgment of the investigator.
- Concurrent cognitive behavioral psychotherapy.
- Present or past (within 3 months) DSM-IV diagnosis of substance abuse/dependence.
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 |
|---|---|---|
| Aripiprazole5-20 mg/day | Drug | – |
Primary outcome
YMRS & CGI
Time frame: 6 weeks
1 secondary outcome
OAS CDRS-R
Time frame: 6 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 27 Jun 2013.
Related trials for Bipolar Disorder
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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.
Robert A Kowatch, MD principal investigator
University of Cincinnati
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aripiprazole in people with Bipolar Disorder, run by University of Cincinnati.
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 12 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 27 Jun 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
YMRS & CGI (time frame: 6 weeks). 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 27 Jun 2013; AzTrials last refreshed its copy on 8 Nov 2026.