Adult Study / OROS Methylphenidate Hydrochloride (HCL) (OROS MPH) in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
NCT00937040, Phase 4, Completed, Ortho-McNeil Janssen Scientific Affairs, LLC; results first posted 2011-08-05
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Adult Study / OROS Methylphenidate Hydrochloride (HCL) (OROS MPH) in Adults With Attention Deficit Hyperactivity Disorder (ADHD) | ClinicalTrials.gov |
| NCT number | NCT00937040 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 357 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Ortho-McNeil Janssen Scientific Affairs, LLC | ClinicalTrials.gov |
| Conditions | Attention Deficit Disorder With Hyperactivity | ClinicalTrials.gov |
| Interventions | OROS MPH, Placebo, OROS MPH Tablets, Placebo Tablets | ClinicalTrials.gov |
| First posted | 2009-07-10 | ClinicalTrials.gov |
| Last updated | 2013-07-30 | ClinicalTrials.gov |
| Results first posted | 2011-08-05 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| 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 | Baseline, endpoint (42 days or early discontinuation) | 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). | ClinicalTrials.gov |
| Secondary | 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) | 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). | ClinicalTrials.gov |
| Secondary | 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) | 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). | ClinicalTrials.gov |
| Secondary | 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) | 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. | ClinicalTrials.gov |
| Secondary | Processing Speed Domain of the Symbol Digit Modalities Test (SDTM) (Cognitive and Executive Function) | Baseline, endpoint (42 days or early discontinuation) | 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). | ClinicalTrials.gov |
| Secondary | Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A) | Baseline, endpoint (42 days or early discontinuation) | 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. | ClinicalTrials.gov |
| Secondary | Performance and Daily Functioning Scale of the Adult ADHD Impact Module (AIM-A) | Baseline, endpoint (42 days or early discontinuation) | 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). | ClinicalTrials.gov |
| Secondary | Subject's Rating of Endicott Work Productivity Scale (EWPS) | Baseline, endpoint (42 days or early discontinuation) | 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. | ClinicalTrials.gov |
| Secondary | Subject's Rating of Dyadic Satisfaction Subscale (DSS) | Baseline, endpoint (42 days or early discontinuation) | 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). | ClinicalTrials.gov |
| Secondary | Subject's Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication You Are Taking for ADHD? | Endpoint (42 days or early discontinuation) | 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). | ClinicalTrials.gov |
| Secondary | Responder Rate Using AISRS | Endpoint (42 days or early discontinuation) | AISRS responder rate is defined as the percentage of subjects with AISRS \< 18 at endpoint. | ClinicalTrials.gov |
| Secondary | Clinical Global Impression - Severity of Illness Subscale (CGI-S) | Baseline, endpoint (42 days or early discontinuation) | 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?". | ClinicalTrials.gov |
| 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 | Baseline, endpoint (42 days or early discontinuation) | 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). | ClinicalTrials.gov |
| Secondary | Designated Observer's (DO) Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A) | Baseline, endpoint (42 days or early discontinuation) | 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. | ClinicalTrials.gov |
| Secondary | Designated Observer's (DO) Rating of Dyadic Satisfaction Subscale | Baseline, endpoint (42 days or early discontinuation) | 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). | ClinicalTrials.gov |
| 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? | Endpoint (42 days or early discontinuation) | 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. | ClinicalTrials.gov |
| Secondary | Adult ADHD Self-Report Scale (ASRS) Over Time | Baseline, endpoint (42 days or early discontinuation) | 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). | ClinicalTrials.gov |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) Total Score | Baseline, endpoint (42 days or early discontinuation) | 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). | ClinicalTrials.gov |
| Secondary | Epworth Sleepiness Scale (ESS) | Baseline, endpoint (42 days or early discontinuation) | 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. | ClinicalTrials.gov |
Outcomes 19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| 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 | Baseline, endpoint (42 days or early discontinuation) | 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). | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | 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) | 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. | milliseconds (msec) | MEAN | ClinicalTrials.gov |
| SECONDARY | 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) | 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. | errors | MEAN | ClinicalTrials.gov |
| SECONDARY | 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) | 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. | correct responses | MEAN | ClinicalTrials.gov |
| SECONDARY | Processing Speed Domain of the Symbol Digit Modalities Test (SDTM) (Cognitive and Executive Function) | Baseline, endpoint (42 days or early discontinuation) | 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. | acccurate responses per minute | MEAN | ClinicalTrials.gov |
| SECONDARY | Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A) | Baseline, endpoint (42 days or early discontinuation) | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Performance and Daily Functioning Scale of the Adult ADHD Impact Module (AIM-A) | Baseline, endpoint (42 days or early discontinuation) | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Subject's Rating of Endicott Work Productivity Scale (EWPS) | Baseline, endpoint (42 days or early discontinuation) | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Subject's Rating of Dyadic Satisfaction Subscale (DSS) | Baseline, endpoint (42 days or early discontinuation) | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Subject's Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication You Are Taking for ADHD? | Endpoint (42 days or early discontinuation) | Intent-to-Treat (ITT) analysis set for non-missing response to this question | Participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Responder Rate Using AISRS | Endpoint (42 days or early discontinuation) | Intent-to-Treat (ITT) analysis set | Percent of participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Clinical Global Impression - Severity of Illness Subscale (CGI-S) | Baseline, endpoint (42 days or early discontinuation) | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| 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 | Baseline, endpoint (42 days or early discontinuation) | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Designated Observer's (DO) Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A) | Baseline, endpoint (42 days or early discontinuation) | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Designated Observer's (DO) Rating of Dyadic Satisfaction Subscale | Baseline, endpoint (42 days or early discontinuation) | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| 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? | Endpoint (42 days or early discontinuation) | Intent-to-Treat (ITT) analysis set for non-missing response to this question | Participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Adult ADHD Self-Report Scale (ASRS) Over Time | Baseline, endpoint (42 days or early discontinuation) | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Pittsburgh Sleep Quality Index (PSQI) Total Score | Baseline, endpoint (42 days or early discontinuation) | 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. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Epworth Sleepiness Scale (ESS) | Baseline, endpoint (42 days or early discontinuation) | 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. | units on a scale | MEAN | ClinicalTrials.gov |
Results by group 130
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
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 | PLACEBO | Baseline | 37.0 | Standard Deviation 7.51 | units on a scale | ClinicalTrials.gov |
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 | OROS MPH | Baseline | 37.8 | Standard Deviation 6.94 | units on a scale | ClinicalTrials.gov |
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 | PLACEBO | Endpoint | 25.2 | Standard Deviation 13.47 | units on a scale | ClinicalTrials.gov |
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 | OROS MPH | Endpoint | 20.7 | Standard Deviation 12.76 | units on a scale | ClinicalTrials.gov |
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 | PLACEBO | Change from baseline at endpoint | -11.7 | Standard Deviation 13.30 | units on a scale | ClinicalTrials.gov |
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 | OROS MPH | Change from baseline at endpoint | -17.1 | Standard Deviation 12.44 | units on a scale | ClinicalTrials.gov |
| Reaction Time Domain of the Stroop Test (Cognitive and Executive Function) | PLACEBO | Baseline (N=140,132) | 708.0 | Standard Deviation 134.36 | milliseconds (msec) | ClinicalTrials.gov |
| Reaction Time Domain of the Stroop Test (Cognitive and Executive Function) | OROS MPH | Baseline (N=140,132) | 700.3 | Standard Deviation 141.09 | milliseconds (msec) | ClinicalTrials.gov |
| Reaction Time Domain of the Stroop Test (Cognitive and Executive Function) | PLACEBO | Endpoint (N=108,114) | 653.2 | Standard Deviation 108.68 | milliseconds (msec) | ClinicalTrials.gov |
| Reaction Time Domain of the Stroop Test (Cognitive and Executive Function) | OROS MPH | Endpoint (N=108,114) | 645.2 | Standard Deviation 116.56 | milliseconds (msec) | ClinicalTrials.gov |
| Reaction Time Domain of the Stroop Test (Cognitive and Executive Function) | PLACEBO | Change from baseline at endpoint (N=103,101) | -39.8 | Standard Deviation 118.16 | milliseconds (msec) | ClinicalTrials.gov |
| Reaction Time Domain of the Stroop Test (Cognitive and Executive Function) | OROS MPH | Change from baseline at endpoint (N=103,101) | -51.2 | Standard Deviation 123.45 | milliseconds (msec) | ClinicalTrials.gov |
| Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function) | PLACEBO | Baseline (N=140,132) | 28.2 | Standard Deviation 39.43 | errors | ClinicalTrials.gov |
| Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function) | OROS MPH | Baseline (N=140,132) | 35.7 | Standard Deviation 47.15 | errors | ClinicalTrials.gov |
| Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function) | PLACEBO | Endpoint (N=108,114) | 27.2 | Standard Deviation 43.97 | errors | ClinicalTrials.gov |
| Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function) | OROS MPH | Endpoint (N=108,114) | 23.9 | Standard Deviation 37.04 | errors | ClinicalTrials.gov |
| Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function) | PLACEBO | Change from baseline at endpoint (N=103,101) | -0.2 | Standard Deviation 47.98 | errors | ClinicalTrials.gov |
| Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function) | OROS MPH | Change from baseline at endpoint (N=103,101) | -10.4 | Standard Deviation 45.82 | errors | ClinicalTrials.gov |
| Cognitive Flexibility Domain of the Stroop/SAT Tests (Cognitive and Executive Function) | PLACEBO | Baseline (N=140,132) | 34.0 | Standard Deviation 21.54 | correct responses | ClinicalTrials.gov |
| Cognitive Flexibility Domain of the Stroop/SAT Tests (Cognitive and Executive Function) | OROS MPH | Baseline (N=140,132) | 31.5 | Standard Deviation 21.57 | correct responses | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | PLACEBO | 179 | ClinicalTrials.gov | |
| Overall Study | STARTED | OROS MPH | 178 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | PLACEBO | 138 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | OROS MPH | 141 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | PLACEBO | 41 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | OROS MPH | 37 | ClinicalTrials.gov |
Adverse events 24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | PLACEBO | 20 | 175 | ClinicalTrials.gov | |
| other | Headache | Nervous system disorders | OROS MPH | 33 | 174 | ClinicalTrials.gov | |
| other | Nausea | Gastrointestinal disorders | PLACEBO | 8 | 175 | ClinicalTrials.gov | |
| other | Nausea | Gastrointestinal disorders | OROS MPH | 9 | 174 | ClinicalTrials.gov | |
| other | Dry Mouth | Gastrointestinal disorders | PLACEBO | 3 | 175 | ClinicalTrials.gov | |
| other | Dry Mouth | Gastrointestinal disorders | OROS MPH | 27 | 174 | ClinicalTrials.gov | |
| other | Upper Respiratory Tract Infection | Infections and infestations | PLACEBO | 9 | 175 | ClinicalTrials.gov | |
| other | Upper Respiratory Tract Infection | Infections and infestations | OROS MPH | 9 | 174 | ClinicalTrials.gov | |
| other | Irritability | General disorders | PLACEBO | 6 | 175 | ClinicalTrials.gov | |
| other | Irritability | General disorders | OROS MPH | 11 | 174 | ClinicalTrials.gov | |
| other | Feeling Jittery | General disorders | PLACEBO | 2 | 175 | ClinicalTrials.gov | |
| other | Feeling Jittery | General disorders | OROS MPH | 11 | 174 | ClinicalTrials.gov | |
| other | Insomnia | Psychiatric disorders | PLACEBO | 4 | 175 | ClinicalTrials.gov | |
| other | Insomnia | Psychiatric disorders | OROS MPH | 12 | 174 | ClinicalTrials.gov | |
| other | Initial Insomnia | Psychiatric disorders | PLACEBO | 3 | 175 | ClinicalTrials.gov | |
| other | Initial Insomnia | Psychiatric disorders | OROS MPH | 17 | 174 | ClinicalTrials.gov | |
| other | Anxiety | Psychiatric disorders | PLACEBO | 2 | 175 | ClinicalTrials.gov | |
| other | Anxiety | Psychiatric disorders | OROS MPH | 12 | 174 | ClinicalTrials.gov | |
| other | Decreased Appetite | Metabolism and nutrition disorders | PLACEBO | 7 | 175 | ClinicalTrials.gov | |
| other | Decreased Appetite | Metabolism and nutrition disorders | OROS MPH | 25 | 174 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | PLACEBO | ClinicalTrials.gov | ||
| Total, all-cause mortality | OROS MPH | ClinicalTrials.gov | ||
| Total, other adverse events | PLACEBO | 49 | 175 | ClinicalTrials.gov |
| Total, other adverse events | OROS MPH | 100 | 174 | ClinicalTrials.gov |
| Total, serious adverse events | PLACEBO | 1 | 175 | ClinicalTrials.gov |
| Total, serious adverse events | OROS MPH | 0 | 174 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 27487193 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| OROS MPH vs PLACEBO: serious adverse events | Trial comparisons |
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Continuous Performance Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)