Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD
August 6, 2008 updated by: Federal University of Rio Grande do Sul
Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Cross-Over 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 associated with Methylphenidate (MPH)for the treatment of children and adolescents with bipolar disorder comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not have an adequate response in ADHD symptoms.
The study design is a 4-week randomized, double blind, cross-over group trial.
Patients were randomized to aripiprazole + MPH or aripiprazole + placebo.
The main hypothesis is: Aripiprazole + MPH will significantly reduce ADHD scores compared to aripiprazole + placebo.
Study Overview
Status
Completed
Intervention / Treatment
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 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 associated with Methylphenidate (MPH) for the treatment of 20 children and adolescents (age range: 8 to 17 years-old) with Bipolar Disorder comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not have an adequate response in ADHD symptoms.
The study design is a 4-week randomized, double blind, cross-over group trial.
Patients were randomized to aripiprazole + MPH or aripiprazole + placebo.
The hypotheses are: 1) Aripiprazole + MPH will significantly reduce ADHD scores compared to aripiprazole + placebo.
2) Patients receiving aripiprazole + MPH will not deteriorate in maniac symptoms.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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RS
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Porto Alegre, RS, Brazil, 90035-003
- ADHD Outpatient Program
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 8 -17
- BD type I or II comorbid with ADHD
- Reduction of maniac symptoms (30% reduction in the YMRS scores and/or CGI scores ≤ 2)while using aripiprazole during a previous study (NCT00116259)without improvement of ADHD symptoms (reduction in ADHD symptoms < 30% in the SNAP-IV). Those receiving placebo in the previous protocol will receive a 6- week open label treatment with aripiprazole. The same threshold for reducing maniac symptoms and absence of response in ADHD symptoms will be used.
Exclusion Criteria:
- IQ < 70
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Weight
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Scores in the Young Mania Rating Scale (BD)
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Scores in the SNAP-IV (ADHD)
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Secondary Outcome Measures
Outcome Measure |
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Scores in the CMRS-P
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Scores in CGI
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Scores in the CDRS
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Scores in the Kutcher Adolescent Depression Scale
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Scores of quality of life (YQOL-R)
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Report of side events
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Scheffer RE, Kowatch RA, Carmody T, Rush AJ. Randomized, placebo-controlled trial of mixed amphetamine salts for symptoms of comorbid ADHD in pediatric bipolar disorder after mood stabilization with divalproex sodium. Am J Psychiatry. 2005 Jan;162(1):58-64. doi: 10.1176/appi.ajp.162.1.58.
- 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.
- Zeni CP, Tramontina S, Ketzer CR, Pheula GF, Rohde LA. Methylphenidate combined with aripiprazole in children and adolescents with bipolar disorder and attention-deficit/hyperactivity disorder: a randomized crossover trial. J Child Adolesc Psychopharmacol. 2009 Oct;19(5):553-61. doi: 10.1089/cap.2009.0037.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
March 19, 2006
First Submitted That Met QC Criteria
March 19, 2006
First Posted (Estimate)
March 21, 2006
Study Record Updates
Last Update Posted (Estimate)
August 7, 2008
Last Update Submitted That Met QC Criteria
August 6, 2008
Last Verified
March 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Bipolar and Related Disorders
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Disease
- Bipolar Disorder
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
Other Study ID Numbers
- GPPG03-325b
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.