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

April 24, 2014 updated by: Janssen-Cilag International NV

A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate Efficacy and Safety of Prolonged Release (PR) OROS Methylphenidate (54 and 72 mg/Day) in Adults With Attention Deficit/Hyperactivity Disorder

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary objective 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). The primary efficacy criterion will be the change in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale (CAARS), from start of treatment to the end of the double-blind treatment. Hypothesis of the primary objective states that either PR OROS methylphenidate dose is more effective than placebo after 13 weeks of treatment in adult patients with ADHD. This is a multicentre, double-blind, randomized, placebo-controlled, parallel group, dose-response study. Patients will be randomized into one of 3 treatment groups to receive oral dosages of PR OROS methylphenidate 54 or 72 mg, or placebo once daily. The study includes a treatment period of 13 weeks. Patients will be titrated from a starting dose of 36 mg/day for 7 days, to 54 or 72 mg/day at Day 8, after which treatment will be administered for 12 weeks. The study will include a screening period of up to 2 weeks, during which current therapy, not allowed during the study can be tapered down and discontinued (with the exception of fluoxetine or MAO (monoamine oxidase) inhibitors for which a maximum screening period of 4 weeks will be allowed). A post-study visit for collection of additional efficacy and safety data will be scheduled for one week after a patient's final dose of study drug. Adults with a diagnosis of ADHD according to DSM-IV criteria with some symptoms before age 7 years that continue to meet these criteria at the time of assessment will be enrolled in this study. ADHD is not diagnosed if the symptoms are better accounted for by another psychiatric disorder (e.g. mood disorder, anxiety disorder, psychotic disorder, personality disorder). The patient (and if possible, informant) must also describe a chronic course of ADHD symptomatology from childhood to adulthood. The description of this chronic course can be patient-based and previous documented diagnosis and/or treatment is not required. Approximately 300 patients (100 in each randomized treatment group) will participate in this study. The primary efficacy criterion will be the change in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated CAARS from baseline to the end of treatment (end of 13 weeks or last post-baseline assessment). This variable will be compared between each dosage group and placebo using an ANCOVA model. Other end points will include changes from baseline to the end of the treatment in the CAARS subscales and assessment of the clinical global impression - global change subscale (CGI-C). Onset of therapeutic effect and responder rate will also be determined. In addition, morning / evening (8 pm) CAARS-S:S assessments will be performed at baseline and on Days 34, 35, 90 and 91. Safety evaluations will include monitoring of adverse events (AEs), clinical laboratory tests (hematology; biochemistry), pregnancy testing, vital signs (supine and standing blood pressure, pulse) and weight, ECG. Patients will be randomized to receive PR OROS methylphenidate 54 or 72 mg, or placebo once daily. Study drug will be administered daily in the morning for up to 13 weeks. Since there is no food effect with methylphenidate, drug administration can be under fed or fasted conditions. Patients will start at a dosage of 36 mg. At Week 2, patients will receive 54 or 72 mg PR OROS methylphenidate for 12 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
279

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
      • Bruxelles, Belgium
      • Kortenberg, Belgium
      • Mechelen, Belgium
      • Mons, Belgium
  • Denmark
      • Hjørring, Denmark
      • Holstebro, Denmark
      • Århus, Denmark
  • Finland
      • Helsinki, Finland
      • Oulu, Finland
      • Pori, Finland
  • France
      • Montpellier, France
      • Nice Cedex 3, France
      • Paris, France
  • Germany
      • Ahrensburg, Germany
      • Aschaffenburg, Germany
      • Berlin, Germany
      • Düsseldorf, Germany
      • Essen, Germany
      • Freiburg, Germany
      • Mannheim, Germany
      • München, Germany
      • Saarbrücken, Germany
      • Würzburg, Germany
  • Netherlands
      • 'S-Gravenhage, Netherlands
      • Nijmegen, Netherlands
  • Norway
      • Bryne, Norway
      • Oslo, Norway
      • Ottestad, Norway
      • Skien, Norway
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
  • Sweden
      • Huddinge, Sweden
      • Linköping, Sweden
      • Lund, Sweden
      • Malmö, Sweden
      • Uppsala, Sweden
      • Örebro, Sweden
  • Switzerland
      • Basel Bs, Switzerland
      • Zurich, Switzerland
  • United Kingdom
      • Cambridge, United Kingdom
      • Swansea, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 001
prolonged release (PR) OROS methylphenidate 54 mg 18+36mg once daily for 13 weeks
Drug: prolonged release (PR) OROS methylphenidate 54 mg
18+36mg once daily for 13 weeks
EXPERIMENTAL: 002
prolonged release (PR) OROS methylphenidate 72 mg 2x36mg once daily for 13 weeks
Drug: prolonged release (PR) OROS methylphenidate 72 mg
2x36mg once daily for 13 weeks
PLACEBO_COMPARATOR: 003
Placebo 2xplacebo once daily for 13 weeks
Drug: Placebo
2xplacebo once daily for 13 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS)
Time Frame: from baseline to 13 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Clinical Global Impression-Severity (CGI-S) From Baseline to End of Treatment
Time Frame: from baseline to13 weeks
The CGI-S rating scale is used to rate the severity of a subject's illness on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe illness). The change in CGI-S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment)
from baseline to13 weeks
Clinical Global Impression-Change (CGI-C)
Time Frame: 13 weeks
The CGI-C rating scale is used to rate the change in severity of the subject's illness compared to baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
13 weeks
Change in Conners Adult ADHD Rating Scale Self Report Short Version (CAARS-S:S) Total Score
Time Frame: from baseline to 13 weeks
The CAARS-S:S is a 26-item self-report scale that measures symptoms based on the DSM-IV criteria for ADHD. Respondents were asked to rate items pertaining to their behavior/problems using the following 4-point scale (from 0 = Not at all, never; to 3 = Very much, very frequently). The CAARS-S:S total score range is from 0 (best) to 78 (worse). The change in CAARS-S:S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment)
from baseline to 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag International NV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR014566
  • 42603ATT3013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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