Adult Study / OROS Methylphenidate Hydrochloride (HCL) (OROS MPH) in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

NCT00937040 | Completed Phase 4 Results

• 2 other identifiers: CR015058CONCERTA-ATT-3014
• Study Type: interventional
• Target: 357
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the ADHD symptom response of adults with ADHD treated with OROS MPH to those treated with placebo.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Osmotic Release Oral System (OROS®) Extended Release Methylphenidate HCl; CONCERTA® (OROS MPH)

Outcome Measures

Primary Outcomes (1)

• Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Score (AISRS) Over Time Using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Fourth Edition for Diagnosis

  The Adult ADHD Investigator Symptom Rating Score (AISRS) assesses 18 core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms for adult subjects based on the investigator's rating for each of the symptoms using a four point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The AISRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).

  Baseline, endpoint (42 days or early discontinuation)

Secondary Outcomes (18)

• Reaction Time Domain of the Stroop Test (Cognitive and Executive Function)

  Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint)

• Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function)

  Baseline, endpoint (42 days or early discontinuation)

• Cognitive Flexibility Domain of the Stroop/SAT Tests (Cognitive and Executive Function)

  Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint)

• Processing Speed Domain of the Symbol Digit Modalities Test (SDTM) (Cognitive and Executive Function)

  Baseline, endpoint (42 days or early discontinuation)

• Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A)

  Baseline, endpoint (42 days or early discontinuation)

Study Arms (2)

001

EXPERIMENTAL

OROS MPH Optimal Patient Dose (18 mg-72 mg) once daily by mouth for 6 weeks

Drug: OROS MPH; Drug: OROS MPH Tablets

002

PLACEBO COMPARATOR

Placebo Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily by mouth for 6 weeks

Drug: Placebo; Drug: Placebo Tablets

Interventions

OROS MPH DRUG

Optimal Patient Dose (18 mg-72 mg) once daily for 6 weeks

001

Placebo DRUG

Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily for 6 weeks

002

OROS MPH Tablets DRUG

Optimal Patient Dose (18 mg-72 mg) once daily by mouth for 6 weeks

001

Placebo Tablets DRUG

Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily by mouth for 6 weeks

002

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
• ADHD diagnosis (any type: Combined, Predominantly Inattentive, or Predominantly Hyperactive-Impulsive)
• Patients with an Adult ADHD Investigator Symptom Rating Scale (AISRS) score greater than 24 at screening/baseline
• Ability to read and understand English

You may not qualify if:

• Any significant history of cardiovascular disease or cardiovascular disease detectable via ECG
• History of diagnosis of substance or alcohol dependence or admission/hospitalization for rehabilitation for dependence
• Current neurologic or psychiatric diagnosis that would make patient inappropriate for participation
• Anxiety assessments of moderate or severe
• Depression assessments of moderate or severe
• History or current suicidal thoughts or attempts
• Known allergies, hypersensitivity, or intolerance to OROS MPH

Sponsors & Collaborators

• Ortho-McNeil Janssen Scientific Affairs, LLC: lead

Related Publications (1)

• Goodman DW, Starr HL, Ma YW, Rostain AL, Ascher S, Armstrong RB. Randomized, 6-Week, Placebo-Controlled Study of Treatment for Adult Attention-Deficit/Hyperactivity Disorder: Individualized Dosing of Osmotic-Release Oral System (OROS) Methylphenidate With a Goal of Symptom Remission. J Clin Psychiatry. 2017 Jan;78(1):105-114. doi: 10.4088/JCP.15m10348.

  PMID: 27487193 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: VP Medical Affairs, CNS
• Organization: Ortho-McNeil Janssen Scientific Affairs, LLC

609-730-2136

Study Officials

• Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

  Ortho-McNeil Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: July 10, 2009
• Study Start: July 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: July 30, 2013
• Results First Posted: August 5, 2011

Record last verified: 2013-07