A Study of the Effectiveness and Safety of Prolonged-release Methylphenidate Hydrochloride in Adult Patients With Attention Deficit/Hyperactivity Disorder.

NCT00246220 | Completed Phase 3

• 1 other identifier: CR002479
• Study Type: interventional
• Target: 402
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of three doses of prolonged-release methylphenidate (a central nervous system (CNS) stimulant) in adult patients with attention deficit/hyperactivity disorder (ADHD).

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention deficit/hyperactivity disorder; methylphenidate; central nervous system stimulants

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale at the end of the double-blind phase (5 weeks) compared with placebo.

Secondary Outcomes (1)

• Changes from baseline to the end of treatment in: Conners' Adult ADHD Rating Scale; Clinical Global Impression; Sheehan's Disability Scale; Quality of Life Enjoyment and Satisfaction Questionnaire; and Global Assessment of Effectiveness

Interventions

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:

• Adults with a diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) according to DSM-IV criteria
• 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.)

You may not qualify if:

• Patients known to be a non-responder to methylphenidate or known to have a child who is a non-responder to methylphenidate
• treated with any methylphenidate-containing medication within 1 month of starting the study
• have any clinically unstable psychiatric condition including, but not limited to the following: acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder, anti-social personality disorder, borderline personality disorder
• family history of schizophrenia or affective psychosis
• patients with motor tics or a history of Tourette's syndrome, or with a substance abuse or dependence disorder, an eating disorder, or mental retardation
• using any medications which may affect the evaluation of study results

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Related Publications (2)

• Medori R, Ramos-Quiroga JA, Casas M, Kooij JJ, Niemela A, Trott GE, Lee E, Buitelaar JK. A randomized, placebo-controlled trial of three fixed dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder. Biol Psychiatry. 2008 May 15;63(10):981-9. doi: 10.1016/j.biopsych.2007.11.008. Epub 2008 Jan 22.

  PMID: 18206857 RESULT

• Buitelaar JK, Sobanski E, Stieglitz RD, Dejonckheere J, Waechter S, Schauble B. Predictors of placebo response in adults with attention-deficit/hyperactivity disorder: data from 2 randomized trials of osmotic-release oral system methylphenidate. J Clin Psychiatry. 2012 Aug;73(8):1097-102. doi: 10.4088/JCP.11m07528. Epub 2012 Jun 12.

  PMID: 22780962 DERIVED

Related Links

• A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study Evaluating Safety \& Efficacy of CONCERTA OROS (18, 36 and 72 mg/day) With Open-Label (OL) Extension in Adults with ADHD
• \|A Multicentre, Randomized, DB, PCB controlled, Parallel Group, Dose-Response Study to Evaluate Safety and Efficacy of Prolonged Release OROS®methylphenidate (18, 36 and 72 mg/day), With OL Extension, in Adults with ADH

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 Pharmaceutica N.V. Clinical Trial

  Janssen Pharmaceutica N.V.

  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: October 28, 2005
• First Posted: October 31, 2005
• Study Start: March 1, 2005
• Study Completion: November 1, 2006
• Last Updated: May 17, 2011

Record last verified: 2010-04