An Effectiveness and Safety Study of CONCERTA® (Methylphenidate Hydrochloride) in the Treatment of Adolescents With Attention Deficit Hyperactivity Disorder
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00249353 |
|
Recruitment Status :
Completed
First Posted : November 7, 2005
Last Update Posted : April 28, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Attention Deficit Disorder With Hyperactivity | Drug: methylphenidate hydrochloride | Phase 3 |
The objective of this study is to evaluate the safety and effectiveness of CONCERTA® (methylphenidate hydrochloride) in the treatment of adolescents with Attention Deficit Hyperactivity Disorder (ADHD). This is a multicenter, randomized, double-blind, placebo-controlled study with adolescents ages 13-18 diagnosed with ADHD. The study consists of four phases. The Screening Phase establishes the diagnosis of ADHD and provides a one-week washout period without any ADHD medication. The Open-Label Titration Phase initiates the treatment of patients with one CONCERTA® 18 mg daily. Thereafter, the dose is increased approximately every 7 days in 18 mg increments (to a maximum of 72 mg daily), until an individualized dose is identified, based on the clinical judgment of the investigator. During the Double-Blind Phase, subjects are randomized to receive either their individualized CONCERTA® dose or a placebo, for a period of 2 weeks. Subjects who successfully complete the Double-Blind Phase are eligible to receive CONCERTA® for an 8-week, Open-Label, Follow-up Phase. The primary efficacy measurement is the total score of the ADHD Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase. Safety assessments include monitoring adverse events, electrocardiograms (ECG), blood pressure, pulse, height and weight throughout the course of the study. The study hypothesis is that CONCERTA® is more effective than placebo in the treatment of Attention Deficit Hyperactivity Disorder in adolescents, and is well tolerated.
Titration Phase: CONCERTA® 18 mg taken orally, once daily, and increased approximately every 7 days in 18 mg increments up to a maximum daily dose of 72 mg. Double-Blind Phase: Individualized dose of CONCERTA® or placebo for 2 weeks. Open-Label Phase: Individualized dose of CONCERTA® for 8 weeks.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 220 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | An Evaluation of the Safety and Effectiveness of CONCERTA® (Methylphenidate Hydrochloride), up to 72 mg Daily, in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) |
| Study Start Date : | March 2002 |
| Actual Study Completion Date : | October 2002 |
- Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.
- Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale score, parent-evaluated weekly during Titration and Double-Blind Phases; Global Assessment of Effectiveness measured weekly during the Titration and Double-Blind Phases; Adverse events
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 13 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Children's Global Assessment Scale rating of 41-70 at baseline (Screening Phase)
Exclusion Criteria:
- Subjects who are known to not respond to methylphenidate
- Have had adverse experiences from methylphenidate or hypersensitivity to CONCERTA or its components
- Have marked anxiety, tension or agitation
- Have glaucoma, ongoing seizure disorder, psychotic disorder, Tourette's disorder or family history of Tourette's disorder
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00249353
| Study Director: | McNeil Consumer & Specialty Pharmaceuticals Clinical Trial | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00249353 |
| Other Study ID Numbers: |
CR002668 |
| First Posted: | November 7, 2005 Key Record Dates |
| Last Update Posted: | April 28, 2010 |
| Last Verified: | April 2010 |
|
Attention Deficit Hyperactivity Disorder ADHD Concerta |
|
Hyperkinesis Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Methylphenidate |
Central Nervous System Stimulants Physiological Effects of Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents |