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Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00305370
First Posted: March 21, 2006
Last Update Posted: August 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of Rio Grande do Sul
  Purpose
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.

Condition Intervention Phase
Bipolar Disorder Attention Deficit Hyperactivity Disorder Drug: Aripiprazole Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Cross-Over Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Scores in the SNAP-IV (ADHD)
  • Scores in the Young Mania Rating Scale (BD)
  • Weight

Secondary Outcome Measures:
  • Scores in CGI
  • Scores in the CMRS-P
  • Scores in the CDRS
  • Scores in the Kutcher Adolescent Depression Scale
  • Scores of quality of life (YQOL-R)
  • Report of side events

Estimated Enrollment: 20
Study Start Date: August 2005
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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.
  Eligibility

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305370


Locations
Brazil
ADHD Outpatient Program
Porto Alegre, RS, Brazil, 90035-003
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Investigators
Principal Investigator: Luis A Rohde, MD Federal University of Rio Grande do Sul
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00305370     History of Changes
Other Study ID Numbers: GPPG03-325b
First Submitted: March 19, 2006
First Posted: March 21, 2006
Last Update Posted: August 7, 2008
Last Verified: March 2006

Keywords provided by Federal University of Rio Grande do Sul:
clinical trial
aripiprazole
methylphenidate
Bipolar Disorder
Attention-Deficit Hyperactivity Disorder
ADHD

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Aripiprazole
Methylphenidate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Stimulants
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents