A Safety and Effectiveness Study of Methylphenidate HCl Extended-release Tablets in Adults With Attention Deficit Hyperactivity Disorder

NCT00326391 | Completed Phase 3

• 1 other identifier: CR011560
• Study Type: interventional
• Target: 229
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of methylphenidate HCl extended-release tablets at five dose levels compared to placebo in adults with Attention Deficit Hyperactivity Disorder (ADHD)

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Disorder with Hyperactivity, ADHD, Attention Deficit Disorder Adult

Outcome Measures

Primary Outcomes (1)

• The change from Baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score as assessed by the Investigator at the Final Visit/2 Week Efficacy Assessment Visit

Secondary Outcomes (1)

• Change from baseline in the AISRS as completed by the Investigator at each Titration Visit. Change from baseline in the AISRS as completed by the Investigator at the end of the study or the last score provided during the study by mg/kg dosing groups.

Interventions

methylphenidate hydrochloride extended-release tablets 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:

• Investigator determined diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria with symptomatology from childhood to adulthood, symptoms present before age seven years and continue to meet full DSM-IV criteria at time of assessment
• Diagnosis confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) at Baseline and Adult ADHD Investigator Symptom Rating Scale (AISRS) score of 24 or greater as determined by the Investigator at Baseline
• Global Assessment of Functioning (GAF) Scale score of 41 to 60, inclusive, at Baseline
• Minimum weight of 100 lbs (45.4 kg) at Screening
• Negative urine drug test at the Screening and Baseline Visits when tested for drugs of abuse

You may not qualify if:

• Known to be non-responders to methylphenidate or other stimulants for the treatment of ADHD
• History of allergy, sensitivity or contraindication to methylphenidate or components of methylphenidate HCL extended-release tablets
• Coexisting medical condition or taking concomitant medication that would interfere with safe administration of methylphenidate in the Investigator's opinion
• Known structural cardiac abnormality
• Diagnosis of or family history of Tourette's syndrome, or motor or verbal tics
• history of seizures or a seizure disorder other than febrile seizures in childhood
• Glaucoma
• Uncontrolled hyperthyroidism or hypothyroidism

Sponsors & Collaborators

• McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.: lead

Related Publications (1)

• Adler LA, Zimmerman B, Starr HL, Silber S, Palumbo J, Orman C, Spencer T. Efficacy and safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, double-blind, parallel group, dose-escalation study. J Clin Psychopharmacol. 2009 Jun;29(3):239-47. doi: 10.1097/JCP.0b013e3181a390ce.

  PMID: 19440077 DERIVED

Related Links

• A Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Titration Study to Evaluate the Efficacy and Safety of CONCERTA� in Adults with Attention Deficit Hyperactivity Disorder at Doses of 36 mg, 54 mg, 72 mg, 90 mg, or 108 mg per day

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Officials

• McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial

  McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 12, 2006
• First Posted: May 16, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: May 24, 2011

Record last verified: 2010-04