| Primary | 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). | Intent-to-Treat (ITT) analysis set was defined as all randomized subjects who have received at least one dose of the study medication and have any post-baseline efficacy data (not including ASRS). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
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| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
| | | Title | Denominators | Categories |
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| Baseline | | | Title | Measurements |
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| - OG00037.0± 7.51
- OG00137.8± 6.94
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| | Endpoint | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Gate-Keeper-Sequence#01. The primary efficacy was tested at the 0.05 level of significance. To control the overall Type I error at 0.05, the secondary efficacy endpoints were tested in a fixed sequence if the preceding null hypothesis was rejected. No further hypotheses could be tested when the preceding null hypothesis was not rejected. All nominal p-values were presented even though the formal testing procedure stopped at the primary endpoint. No unqualified statements can be made. | ANCOVA | P-value for Change from baseline at endpoint. Each outcome involved with gate-keeping will be numbered with a Gate-Keeper-Sequence-Number from 01-16. | <0.001 | P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline AISRS total score. Change from baseline to endpoint uses the latest non-missing score after baseline for each subject. | | | | | | | | |
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| Secondary | Reaction Time Domain of the Stroop Test (Cognitive and Executive Function) | Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The 1st part generates basic "reaction time" to colors. The 2nd part generates "complex reaction time score" to matching color names and font color. The 3rd part establishes a "Stroop reaction time" and an error score to unmatched color names/fonts. Reaction Time Domain Score = (Stroop Complex Reaction Time Correct + Stroop Reaction Time Correct)/2. Lower scores indicate better functioning (i.e. reaction time). | Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint. | Posted | | Mean | Standard Deviation | milliseconds (msec) | | Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint) | | | | ID | Title | Description |
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| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function) | The Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The Shifting Attention Test (SAT) a computerized measure of the ability to shift from one instruction set to another quickly and accurately. The Continuous Performance Test (CPT) is a computerized measure of vigilance or sustained attention/attention over time. Vigilance Domain (Complex Attention) Score = Stroop Commission Errors + SAT Errors + CPT Commission Errors + CPT Omission Errors. Lower scores indicate better functioning (i.e. sustained attention). | Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint. | Posted | | Mean | Standard Deviation | errors | | Baseline, endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Cognitive Flexibility Domain of the Stroop/SAT Tests (Cognitive and Executive Function) | The Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The SAT is a computerized measure of the ability to shift from one instruction set to another quickly and accurately. The scores generated by the SAT are: correct matches, errors, and response time. The testing score is a measure of cognitive flexibility. Cognitive Flexibility Domain Score = SAT Correct Responses - SAT Errors - Stroop Commission Errors. Higher scores indicate better accuracy. | Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint. | Posted | | Mean | Standard Deviation | correct responses | | Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint) | | | | ID | Title | Description |
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| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Processing Speed Domain of the Symbol Digit Modalities Test (SDTM) (Cognitive and Executive Function) | The Symbol Digit Modalities Test (SDMT) is a computerized variant of the Wechsler Digit Symbol Substitution Test (DSST), but the position of symbols and digits is reversed. Scoring is the number of correct responses generated in 2 minutes. Processing Speed Domain = SDMT correct responses - SDMT errors. Higher scores indicate better functioning (i.e. information processing). | Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint. | Posted | | Mean | Standard Deviation | acccurate responses per minute | | Baseline, endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A) | The BRIEF-A is a self-reported measure (low=61, high=225, lower scores indicate higher executive functioning) capturing views of the subject's own functioning in the everyday environment. The BRIEF-A contains 75 scored items (1=never, 2=sometimes, 3=often) in 9 non-overlapping clinical scales (Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials). The Behavioral Regulation Index (BRI), Metacognition Index (MI), and GEC are then derived. | Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Performance and Daily Functioning Scale of the Adult ADHD Impact Module (AIM-A) | The AIM-A is a subject-reported measure (low=0, high=100, a higher score is more favorable) to assess the overall impact and role that ADHD may have in the conduct of tasks that are expected of adults. The AIM-A is comprised of four global quality of life items, five economic impact items, and five multi-item scales that describe important concepts. Items include: Living with ADHD; General Well-Being; Work, Home and School Performance and Daily Functioning; Relationships; and Communication; and Impact of Symptoms (emotional, degree of daily interference). | Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Subject's Rating of Endicott Work Productivity Scale (EWPS) | The EWPS provides a measure of the subject's report of their overall productivity (low=0, high=100, a higher score indicates worsening work productivity and efficiency). There are 25 items (questions 15-39) on the scale that describe types of behaviors/ subjective feelings that are highly likely to reduce work productivity/efficiency. These 25 items are rated on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, to 4=almost always) indicating how often the behavior, feeling or attitude has been manifested in the past week. The total score is the sum of the 25 items. | Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Subject's Rating of Dyadic Satisfaction Subscale (DSS) | The Dyadic Adjustment Scale (DAS) assesses the relationship satisfaction or adjustment of partners in committed couple relationships. The 32-question DAS includes 4 empirically validated subscales that measure: dyadic satisfaction, dyadic consensus, dyadic cohesion and affectional expression. The response format varies across the entire scale and includes 5-, 6-, and 7-point Likert-scale questions and two yes/no items. The 10-question subset of the DAS, the Dyadic Satisfaction Subscale, was used in this study (low=0, high=50, higher score means better relationship satisfaction). | Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Subject's Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication You Are Taking for ADHD? | The satisfaction with treatment questionnaire (low=0, high=20, a lower score indicates lower satisfaction with treatment) requires subjects to answer 4 questions related to how much their ADHD symptoms have changed since starting the medication, how much benefit they received from the medication, the extent, if any, the advantages outweighed the disadvantages, and overall satisfaction with the medication. The responses for this question vary with range of satisfaction (e.g. extremely satisfied, very satisfied, satisfied, neutral, dissatisfied, very dissatisfied, or extremely dissatisfied). | Intent-to-Treat (ITT) analysis set for non-missing response to this question | Posted | | Number | | Participants | | Endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
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| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Responder Rate Using AISRS | AISRS responder rate is defined as the percentage of subjects with AISRS < 18 at endpoint. | Intent-to-Treat (ITT) analysis set | Posted | | Number | | Percent of participants | | Endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
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| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Clinical Global Impression - Severity of Illness Subscale (CGI-S) | The Clinical Global Impression - Severity of Illness (CGI-S) is a clinician-rated subscale (low=0, high=7, higher score indicates increasing illness). The clinician rates the severity of the ADHD symptoms in relation to the clinician's total experience with ADHD subjects using a 7-point scale (1=normal, not at all ill, 2= borderline ill, 3= mildly ill, 4=moderately ill, 5= markedly ill, 6= severely ill, 7= among the most extremely ill subjects) in response to the question "Considering your total clinical experience with this particular population, how ill is the subject at this time?". | Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Significant Other's (a Spouse, Significant Other or Other Adult in the Household, Described in This Study as the Designated Observer) Rating of Adult ADHD Rating Scale IV | The ADHD Rating Scale-IV (Significant Other) is an 18-item list of core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms. Each item is rated on a four point Likert type scale (0 = never or rarely, 1 = sometimes, 2 = often, and 3 = very often). The subject's designated observer will complete this scale, with baseline assessment based on the subject's usual functioning when not on medication. The 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). | Intent-to-Treat (ITT) analysis set and non-missing values at each timepoint. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Designated Observer's (DO) Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A) | The BRIEF-A, as completed by the DO, is a measure (low=61, high=225, lower scores indicate higher executive functioning) capturing views of an adult informant familiar with the subject's functioning. The BRIEF-A contains 75 scored items (1=never, 2=sometimes, 3=often) in nine non-overlapping clinical scales (Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials). The Behavioral Regulation Index (BRI), Metacognition Index (MI), and Global Executive Composite (GEC) are then derived. | Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
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| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Designated Observer's (DO) Rating of Dyadic Satisfaction Subscale | The Dyadic Adjustment Scale (DAS) completed by DOs who were spouses or significant others assesses the relationship satisfaction or adjustment of partners in committed couple relationships. The 32-question DAS includes 4 empirically validated subscales that measure: dyadic satisfaction, dyadic consensus, dyadic cohesion and affectional expression. Possible responses include 5-, 6-, and 7-point Likert-scale questions and two yes/no items. The 10-question DAS subset, the Dyadic Satisfaction Subscale, was used in this study (low=0, high=50, higher score means better relationship satisfaction). | Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
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| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Designated Observer's (DO) Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication for ADHD Your Partner is Taking? | The satisfaction with treatment questionnaire (low=0, high=20, a lower score indicates lower satisfaction with treatment) requires the subject's DO to answer 4 questions related to how much the subject's ADHD symptoms have changed since starting the medication, how much benefit was received from the medication, the extent, if any, the advantages outweighed the disadvantages, and overall satisfaction with the medication. Responses vary from extremely satisfied, very satisfied, satisfied, neutral, mildly dissatisfied, dissatisfied, very dissatisfied, or extremely dissatisfied. | Intent-to-Treat (ITT) analysis set for non-missing response to this question | Posted | | Number | | Participants | | Endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
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| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Adult ADHD Self-Report Scale (ASRS) Over Time | The Adult ADHD Self-Report Scale (ASRS) assesses 18 core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms for adult subjects based on the subject's own 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 ASRS 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). | Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
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| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Pittsburgh Sleep Quality Index (PSQI) Total Score | The PSQI discriminates between good and poor sleepers. The self-administered scale contains 15 multiple-choice items concerning frequency of sleep disturbances and subjective sleep quality and 4 write-in items that inquire about typical bedtime, wake-up time, sleep latency, and sleep duration over the past month. The PSQI generates 7 scores corresponding to the different sleep domains. Each component score ranges from 0 to 3. Total sleep index is calculated by adding up the 7 component scores (low=0, high=21, the lower the score, the better in sleep quality). | Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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| Secondary | Epworth Sleepiness Scale (ESS) | The Epworth Sleepiness Scale (ESS) is an 8-item self-rated questionnaire designed to assess the overall level of daytime sleepiness. Each item describes normal daily situations (i.e., watching TV, lying down in the afternoon, sitting inactive in a public place) and subjects rate the likelihood of dozing off or falling asleep in each situation. Responses use a 4-point rating scale (0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing). Item scores are summed to produce a total score (range of 0-24) with lower score suggesting more alertness. | Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, endpoint (42 days or early discontinuation) | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo | | OG001 | OROS MPH | Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA |
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