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

This study has been completed.
Sponsor:
Information provided by:
Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00305370
First received: March 19, 2006
Last updated: August 6, 2008
Last verified: March 2006
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
ClinicalTrials.gov Identifier: NCT00305370     History of Changes
Other Study ID Numbers: GPPG03-325b
Study First Received: March 19, 2006
Last Updated: August 6, 2008
Health Authority: Brazil: National Committee of Ethics in Research

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:
Attention Deficit Disorder with Hyperactivity
Bipolar Disorder
Disease
Hyperkinesis
Affective Disorders, Psychotic
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Mood Disorders
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Aripiprazole
Methylphenidate
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014