CONCERTA (OROS Methylphenidate Hydrochloride) for the Treatment of Attention Deficit Hyperactivity Disorder in Adults

NCT00246207 | Completed Phase 3

• 1 other identifier: CR003097
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this pilot study is to evaluate the safety, tolerability and potential effectiveness of CONCERTA® (methylphenidate hydrochloride extended-release tablets), a central nervous system (CNS) stimulant for the treatment of adults with Attention Deficit Hyperactivity Disorder (ADHD).

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Hyperactivity Disorder; once-day oral tablets

Outcome Measures

Primary Outcomes (1)

• The primary effectiveness outcomes will be the changes in the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated CAARS (Conners' Adult ADHD Rating Scale) from baseline to the end of treatment.

Secondary Outcomes (1)

• The changes in other effectiveness assessments will be secondary endpoints.

Interventions

CONCERTA (OROS methylphenidate hydrochloride) DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) according to the Diagnostic and Statistical Manual of Mental Diseases (DSM-IV) obtained via clinical interview and confirmed by the Wender Utah Rating Scale
• ADHD symptoms from childhood to adulthood, with some symptoms present before age 7 years which continue to meet DSM-IV criteria at the time of assessment. (ADHD is not diagnosed if the symptoms are better accounted for by another psychiatric disorder.)
• investigator-rated CAARS (Conners' Adult ADHD Rating Scale) baseline score greater than or equal to 24
• Clinical Global Impression of Severity baseline score greater than or equal to 4 and a total Montgomery Asberg Depression Rating score at baseline of less than or equal to 16.

You may not qualify if:

• Have been treated with any methylphenidate- or amphetamine-containing medication within 4 weeks of screening visit
• any clinically unstable psychiatric condition including the following, but not limited to: acute mood disorder, schizophrenia, bipolar disorder, acute obsessive compulsive disorder, anti-social personality disorder
• subjects with marked anxiety, tension, aggression or agitation, Autism or Asperger's syndrome
• a diagnosis of substance abuse or dependence within 6 months prior to screening evaluation
• use of other psychotropic medications used to treat non-ADHD psychiatric disorders, if the dose of the medication has not remained stable for a minimum of 4 weeks prior to trial entry.

Sponsors & Collaborators

• Janssen-Ortho Inc., Canada: lead

Related Publications (1)

• Fallu A, Richard C, Prinzo R, Binder C. Does OROS-methylphenidate improve core symptoms and deficits in executive function? Results of an open-label trial in adults with attention deficit hyperactivity disorder. Curr Med Res Opin. 2006 Dec;22(12):2557-66. doi: 10.1185/030079906X154132.

  PMID: 17166338 RESULT

Related Links

• An open-label study evaluating the safety and effectiveness of OROS\* Methylphenidate (CONCERTA\*) in adults with Attention Deficit Hyperactivity Disorder

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Janssen-Ortho Inc. Clinical Trial

  Janssen-Ortho Inc., Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: October 31, 2005
• Study Start: March 1, 2005
• Study Completion: December 1, 2005
• Last Updated: February 10, 2012

Record last verified: 2012-02