Bipolar DisorderNCT00116259
Aripiprazole in Children and Adolescents With Bipolar Disorder and Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Aripiprazole in people with Bipolar Disorder and Attention Deficit Hyperactivity Disorder, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder. This study aims to assess the efficacy of Aripiprazole (a novel anti-psychotic drug) for the treatment of children and adolescents with bipolar disorder comorbid with ADHD. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Bipolar Disorder, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Aripiprazole
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2005to Feb 2008
- Phase
- Interventional
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 8-17
- BD type I or II comorbid with ADHD
- Baseline score in the YMRS > or = 20
Who cannot join
- IQ < 70
- Pharmacologic treatment in the last month
- Pregnancy or absence of a contraceptive method in fertile girls
- Diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency
- Risk of suicide or homicide
- Clinical condition that might interfere in the study
- Known sensibility to aripiprazole
Trial locations and contacts
1 site in 1 country.
Brazil1 site
ADHD outpatient program
Porto Alegre - Brazil, Rio Grande do Sul, 90035-003
About this study
Official title: Aripiprazole in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Double Blind Placebo Controlled Trial
There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder. This study aims to assess the efficacy of Aripiprazole (a novel anti-psychotic drug) for the treatment of children and adolescents with bipolar disorder comorbid with ADHD. The study design is a 8-week randomized, double blind, parallel group trial. Patients were randomized to either aripiprazole or placebo.
The main hypotheses are:
- Aripiprazole will significantly reduce maniac scores compared to placebo
- Aripiprazole will significantly reduce ADHD scores compared to placebo
Read the detailed description
Bipolar disorder (BD) is a chronic disorder that severely affects the normal development of children and adolescents. The disorder is associated with high rates of suicide tentative and high-risk behaviors like sexual promiscuity and drug abuse. Bipolar disorder in children is also associated with high rates of comorbidity, especially with Attention-Deficit Hyperactivity Disorder (ADHD). There is a scarcity of clinical trials assessing the effects of medications in children with BD. Moreover, the frequent presence of comorbid ADHD might determine lower response to treatment. Aripiprazole is a novel anti-psychotic drug. Its mechanism of action seems to be related to a stabilization of dopaminergic transmission, acting as a partial agonist especially in dopaminergic D2 receptors. It also has effects in 5-HT1a serotonergic receptors. Thus, it might have a promising effect in children and adolescents with comorbid BD and ADHD. A retrospective chart review, recently published, suggests the efficacy of this drug in children with BD. This study aims to assess the efficacy of Aripiprazole (a novel anti-psychotic drug) for the treatment of 50 children and adolescents (age range: 08 to 17 years-old) with Bipolar Disorder comorbid with ADHD. The study design is an 6-week randomized, double blind, parallel group trial. Patients were randomized to either aripiprazole or placebo. The hypotheses are: 1) Aripiprazole will significantly reduce maniac scores compared to placebo; 2)Aripiprazole will significantly reduce ADHD scores compared to placebo; 3) Aripiprazole will not be significantly associated to weight gain compared to placebo.
- Being tested
- Aripiprazole
- Keywords
- clinical trial, aripiprazole, Bipolar Disorder, Attention-Deficit Hyperactivity Disorder, ADHD
- Medical subject headings
- Bipolar Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores in the Young Mania Rating Scale (BD)
Scores in the SNAP-IV (ADHD)
Weight
Secondary outcomes (6)
Scores in the CMRS-P
Scores in CGI
Scores in the CDRS
Scores in the Kutcher Adolescent Depression Scale
Scores of quality of life (YQOL-R)
Report of side events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2005 (estimated)
- Study startMar 2005
- Primary completionJan 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre
- Investigators
- Luis A Rohde, MD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116259
- Sponsor's protocol ID
- GPPG03-325a
- Other IDs
- GPPG03-325a
- Status last verified
- Aug 2008
- First submitted
- 27 Jun 2005
- Last updated
- 7 Aug 2008
- Results posted
- No
Publications
Biederman J, McDonnell MA, Wozniak J, Spencer T, Aleardi M, Falzone R, Mick E. Aripiprazole in the treatment of pediatric bipolar disorder: a systematic chart review. CNS Spectr. 2005 Feb;10(2):141-8. doi: 10.1017/s1092852900019489.
PubMed 15685125Tramontina S, Zeni CP, Ketzer CR, Pheula GF, Narvaez J, Rohde LA. Aripiprazole in children and adolescents with bipolar disorder comorbid with attention-deficit/hyperactivity disorder: a pilot randomized clinical trial. J Clin Psychiatry. 2009 Apr 21;70(5):756-64. doi: 10.4088/JCP.08m04726.
PubMed 19389329
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aripiprazole in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00116259
- Acronym / sponsor ID
- GPPG03-325a
- Keywords
- clinical trial, aripiprazole, Bipolar Disorder, Attention-Deficit Hyperactivity Disorder, ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre
- Study start
- Mar 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 28 Jun 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.
There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder. This study aims to assess the efficacy of Aripiprazole (a novel anti-psychotic drug) for the treatment of children and adolescents with bipolar disorder comorbid with ADHD. The study design is a 8-week randomized, double blind, parallel group trial. Patients were randomized to either aripiprazole or placebo.
The main hypotheses are:
- Aripiprazole will significantly reduce maniac scores compared to placebo
- Aripiprazole will significantly reduce ADHD scores compared to placebo
Detailed description
Bipolar disorder (BD) is a chronic disorder that severely affects the normal development of children and adolescents. The disorder is associated with high rates of suicide tentative and high-risk behaviors like sexual promiscuity and drug abuse. Bipolar disorder in children is also associated with high rates of comorbidity, especially with Attention-Deficit Hyperactivity Disorder (ADHD). There is a scarcity of clinical trials assessing the effects of medications in children with BD. Moreover, the frequent presence of comorbid ADHD might determine lower response to treatment. Aripiprazole is a novel anti-psychotic drug. Its mechanism of action seems to be related to a stabilization of dopaminergic transmission, acting as a partial agonist especially in dopaminergic D2 receptors. It also has effects in 5-HT1a serotonergic receptors. Thus, it might have a promising effect in children and adolescents with comorbid BD and ADHD. A retrospective chart review, recently published, suggests the efficacy of this drug in children with BD. This study aims to assess the efficacy of Aripiprazole (a novel anti-psychotic drug) for the treatment of 50 children and adolescents (age range: 08 to 17 years-old) with Bipolar Disorder comorbid with ADHD. The study design is an 6-week randomized, double blind, parallel group trial. Patients were randomized to either aripiprazole or placebo. The hypotheses are: 1) Aripiprazole will significantly reduce maniac scores compared to placebo; 2)Aripiprazole will significantly reduce ADHD scores compared to placebo; 3) Aripiprazole will not be significantly associated to weight gain compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 8-17
- BD type I or II comorbid with ADHD
- Baseline score in the YMRS > or = 20
Key exclusion criteria (7 listed)
- IQ < 70
- Pharmacologic treatment in the last month
- Pregnancy or absence of a contraceptive method in fertile girls
- Diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency
- Risk of suicide or homicide
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 | Drug | – |
Primary outcome
Scores in the Young Mania Rating Scale (BD)
Scores in the SNAP-IV (ADHD)
Weight
6 secondary outcomes
Scores in the CMRS-P
Scores in CGI
Scores in the CDRS
Scores in the Kutcher Adolescent Depression Scale
Scores of quality of life (YQOL-R)
Report of side events
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 7 Aug 2008.
- Background: PubMed 15685125Biederman J, McDonnell MA, Wozniak J, Spencer T, Aleardi M, Falzone R, Mick E. Aripiprazole in the treatment of pediatric bipolar disorder: a systematic chart review. CNS Spectr. 2005 Feb;10(2):141-8. doi: 10.1017/s1092852900019489.
- Derived from this study: PubMed 19389329Tramontina S, Zeni CP, Ketzer CR, Pheula GF, Narvaez J, Rohde LA. Aripiprazole in children and adolescents with bipolar disorder comorbid with attention-deficit/hyperactivity disorder: a pilot randomized clinical trial. J Clin Psychiatry. 2009 Apr 21;70(5):756-64. doi: 10.4088/JCP.08m04726.
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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.
Luis A Rohde, MD principal investigator
Federal University of Rio Grande do Sul
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 Attention Deficit Hyperactivity Disorder, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 3 inclusion and 7 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 7 Aug 2008. 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 Brazil. 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?
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 in the Young Mania Rating Scale (BD). The study lists 3 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 NCT00116259, which also lists 2 linked publications.
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 7 Aug 2008.