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

NCT00305370 | Completed Phase 4

• 1 other identifier: GPPG03-325b
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Bipolar Disorder; Attention Deficit Hyperactivity Disorder

Keywords

clinical trial; aripiprazole; methylphenidate; Bipolar Disorder; Attention-Deficit Hyperactivity Disorder; ADHD

Outcome Measures

Primary Outcomes (3)

• Scores in the SNAP-IV (ADHD)

• Scores in the Young Mania Rating Scale (BD)

• Weight

Secondary Outcomes (6)

• 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)

Interventions

Aripiprazole DRUG

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

ADHD Outpatient Program

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Related Publications (3)

• 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.

  PMID: 15625202 BACKGROUND

• 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.

  PMID: 15685125 RESULT

• 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.

  PMID: 19877980 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Attention Deficit Disorder with Hyperactivity

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Luis A Rohde, MD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 19, 2006
• First Posted: March 21, 2006
• Study Start: August 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: March 1, 2008
• Last Updated: August 7, 2008

Record last verified: 2006-03

Locations

BR (1)