A Study to Evaluate Effectiveness and Safety of Prolonged Release OROS Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder

NCT00714688 | Completed Phase 3 Results

• 2 other identifiers: CR01456642603ATT3013
• Study Type: interventional
• Target: 279
• Locations: 11 countries
• Sites: 42

Brief Summary

The purpose of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with attention deficit/hyperactivity disorder (ADHD).

Conditions

Attention Deficit/ Hyperactivity Disorder

Keywords

Adult; ADHD; Concerta

Outcome Measures

Primary Outcomes (1)

• Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS)

  The primary endpoint was the change in the ADHD symptoms total score of the investigator-rated CAARS from baseline to the last assessment in the double-blind treatment period. CAARS assesses ADHD symptoms and behaviors in adults using a scale ranging from 0 (best) to 54 (worst). For subjects without a post-baseline efficacy measurement, a change of 0 units was imputed.

  from baseline to 13 weeks

Secondary Outcomes (3)

• Change in Clinical Global Impression-Severity (CGI-S) From Baseline to End of Treatment

  from baseline to13 weeks

• Clinical Global Impression-Change (CGI-C)

  13 weeks

• Change in Conners Adult ADHD Rating Scale Self Report Short Version (CAARS-S:S) Total Score

  from baseline to 13 weeks

Study Arms (3)

001

EXPERIMENTAL

prolonged release (PR) OROS methylphenidate 54 mg 18+36mg once daily for 13 weeks

Drug: prolonged release (PR) OROS methylphenidate 54 mg

002

EXPERIMENTAL

prolonged release (PR) OROS methylphenidate 72 mg 2x36mg once daily for 13 weeks

Drug: prolonged release (PR) OROS methylphenidate 72 mg

003

PLACEBO COMPARATOR

Placebo 2xplacebo once daily for 13 weeks

Drug: Placebo

Interventions

prolonged release (PR) OROS methylphenidate 54 mg DRUG

18+36mg once daily for 13 weeks

001

prolonged release (PR) OROS methylphenidate 72 mg DRUG

2x36mg once daily for 13 weeks

002

Placebo DRUG

2xplacebo once daily for 13 weeks

003

Eligibility Criteria

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

You may qualify if:

• Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) and confirmed by the Conners' Adult ADHD Diagnostic Interview for DSM IV
• Described chronic course of ADHD symptomatology from childhood to adulthood, with some symptoms present before age 7 years and continue to meet DSM-IV criteria at the time of assessment
• CAARS score of at least or equal to 24 as determined by investigator at screening visit
• Patient agrees to take only the supplied study drug as treatment for ADHD during the study
• Patient agrees not to initiate a new behavioral modification program during the study or if currently using a behavioral modification program agrees not to change this program during the study.

You may not qualify if:

• Known to be a non-responder to methylphenidate, or patient has a child known to be a non-responder to methylphenidate
• Has been treated with any methylphenidate-containing medication within 1 month of screening visit
• Participation in and premature withdrawal from 42603ATT3002, CR002479 or 42603ATT3004, CR011068 study
• Known allergy or hypersensitivity to methylphenidate, or components of PR OROS methylphenidate
• Any clinically unstable psychiatric condition including, but not limited to the following: acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder (OCD), anti-social personality disorder, borderline personality disorder.

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (42)

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Antwerp, Belgium

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Brussels, Belgium

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Kortenberg, Belgium

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Mechelen, Belgium

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Mons, Belgium

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Aarhus, Denmark

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Hjørring, Denmark

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Holstebro, Denmark

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Helsinki, Finland

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Oulu, Finland

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Pori, Finland

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Montpellier, France

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Nice, France

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Paris, France

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Ahrensburg, Germany

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Aschaffenburg, Germany

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Berlin, Germany

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Düsseldorf, Germany

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Essen, Germany

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Freiburg im Breisgau, Germany

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Mannheim, Germany

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München, Germany

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Saarbrücken, Germany

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Würzburg, Germany

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Nijmegen, Netherlands

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The Hague, Netherlands

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Bryne, Norway

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Oslo, Norway

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Ottestad, Norway

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Skien, Norway

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Barcelona, Spain

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Madrid, Spain

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Huddinge, Sweden

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Linköping, Sweden

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Lund, Sweden

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Malmo, Sweden

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Örebro, Sweden

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Uppsala, Sweden

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Basel Bs, Switzerland

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Zurich, Switzerland

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Cambridge, United Kingdom

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Swansea, United Kingdom

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MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study was not designed to statistically compare the 54 mg with the 72 mg dose. Study medication was not titrated to the assigned dose as in clinical practice. This could have differentially affected treatment emergence of AEs and patient retention.

Results Point of Contact

• Title: EMEA Medical Affairs Director
• Organization: Janssen-Cilag Germany

+49 2137 955258

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 14, 2008
• Study Start: February 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 8, 2014
• Results First Posted: April 21, 2010

Record last verified: 2014-04

Locations

DK (3); NO (4); NL (2); SE (6); CH (2); GB (2); BE (5); FI (3); FR (3); DE (10); ES (2)