Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD

NCT00585910 | Completed Phase 4 Results

• 1 other identifier: 2003-P-002180
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, effectiveness, and tolerability of atomoxetine and OROS methylphenidate, taken together, in the treatment of ADHD in children and adolescents ages 6-17.

Conditions

ADHD; Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Attention Deficit Hyperactivity Disorder; Strattera; Concerta; Atomoxetine; OROS Methylphenidate

Outcome Measures

Primary Outcomes (1)

• Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)

  The primary outcome was the ADHD rating scale. Change scores for the ADHD Rating Scale (RS), from baseline to endpoint (week 7 or last observation carried forward), were analyzed with paired t-tests and nonparametric Wilcoxon sign-rank tests. The best score is a score of 0 (no ADHD symptoms) and the worst score is the highest score possible (54).

  7 weeks

Secondary Outcomes (1)

• Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders

  7 weeks

Study Arms (1)

1

EXPERIMENTAL

Total treatment period is 7 weeks. Atomoxetine treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate will then be added to his or her treatment regimen for the final 3 weeks of the study.

Drug: Atomoxetine and OROS Methylphenidate

Interventions

Atomoxetine and OROS Methylphenidate DRUG

Subjects must have at least attempted to tolerate a dose of 1.2 mg/kg of atomoxetine. If tolerated, they must remain on this dose for at least two weeks. OROS methylphenidate will be target dosed and titrated to a maximum dose of 54 mg.

Also known as: Strattera, Concerta

1

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female outpatients from 6 to 17 years old.
• Subjects with a DSM-IV diagnosis of ADHD by clinical interview, confirmed by the KSADS-E ADHD module.
• Subject with DSM-IV diagnosis of ADHD without previous treatment.
• Subjects with DSM-IV diagnosis of ADHD with a clinical history of a partial response to ATMX or methylphenidate as monotherapy.
• In phase I, subjects with a CGI-Severity of at least moderate impairment related to their ADHD (CGI \>4).
• In phase II, subjects receiving therapeutic doses of ATMX with at least minor improvement in their clinical picture due to the ATMX as determined operationally (CGI-Improvement score indicating at least minor improvement relative to off-drug baseline) will be included.
• In phase II, only subjects receiving ATMX that also have evidence of persistent symptoms of ADHD and impairment related to their ADHD (a CGI-Severity of \> minor impairment OR ADHD RS \>18; AND GAF score \<65) will have Concerta added to their regimen.
• Subjects' parents must provide informed consent and subjects' assent.

You may not qualify if:

• Pregnant or nursing females or females not using proper contraception.
• Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
• Subjects (or their families) who do not appear to be reliable reporters of their condition or who indicate they will not be able to meet the schedule of visits for the duration of the study.
• Subjects with Mental Retardation or Organic Brain Syndromes.
• Subjects who have a lifetime history of a psychotic or bipolar disorder.
• Subjects with recent or current (past 30 days) major depressive disorder or a clinically significant anxiety disorder that would potentially necessitate treatment during the trial. g. Subjects with recent evidence (past 30 days) of suicidality or homicidality will not be enrolled.
• Subjects with a recent history (e.g. three months) of a substance use disorder; or those with a positive urine for substances of abuse will not be enrolled. Subjects will be told that a positive urine for substances of abuse will be disclosed to their parents.
• Subjects taking stimulants or other psychotropics at the time of the evaluation. Subjects will not be discontinued from their current medication regimen (not including ATMX), unless authorized and supervised by their treating physician.
• Treatment of stimulants within one week of the evaluation; tricyclic antidepressants, bupropion, cholinesterase inhibitors, modafinil, clonidine/guanfacine, lithium/anticonvulsants for behavioral control, or serotonin reuptake inhibitors (except fluoxetine) for four weeks prior to entry are prohibited. Treatment with antipsychotics/neuroleptics and fluoxetine for 8 weeks prior to entry are prohibited.
• Subjects using any prescribed or over-the-counter concurrent treatment for ADHD.
• Subjects with a history of a lack of response to either ATMX or methylphenidate.
• Subjects with a history of a serious adverse event to either ATMX or methylphenidate.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride; Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

* Open trial so may have been biased; * Small sample size which may have underestimated findings; * Used a priori definition of partial response. However, our definition of ATMX partial responders has not been validated.

Results Point of Contact

• Title: Kerry Brodziak
• Organization: Massachusetts General Hospital

kbrodziak@partners.org

617-503-1043

Study Officials

• Timothy Wilens, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: January 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: November 14, 2012
• Results First Posted: May 10, 2010

Record last verified: 2012-11

Locations

US (1)