Phase 4
Completed N=357
Adult Study / OROS Methylphenidate Hydrochloride (HCL) (OROS MPH) in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT00937040 ↗
Enrolled (actual)
357
Serious AEs
0.3%
Results posted
Aug 2011
Primary outcomePrimary: 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 — 37.0; 37.8; 25.2; 20.7 units on a scale — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
37.0; 37.8; 25.2; 20.7; -11.7; -17.1 | <0.001 sig |
| SECONDARY Reaction Time Domain of the Stroop Test (Cognitive and Executive Function) |
708.0; 700.3; 653.2; 645.2; -39.8; -51.2 | 0.206 |
| SECONDARY Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function) |
28.2; 35.7; 27.2; 23.9; -0.2; -10.4 | 0.348 |
| SECONDARY Cognitive Flexibility Domain of the Stroop/SAT Tests (Cognitive and Executive Function) |
34.0; 31.5; 45.9; 46.6; 11.3; 13.9 | 0.324 |
| SECONDARY Processing Speed Domain of the Symbol Digit Modalities Test (SDTM) (Cognitive and Executive Function) |
53.9; 52.8; 59.7; 58.8; 5.9; 4.9 | 0.631 |
| SECONDARY Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A) |
153.3; 153.7; 137.9; 128.4; -14.5; -25.8 | <0.001 sig |
| SECONDARY Performance and Daily Functioning Scale of the Adult ADHD Impact Module (AIM-A) |
36.0; 31.9; 48.5; 59.4; 12.7; 27.5 | <0.001 sig |
| SECONDARY Subject's Rating of Endicott Work Productivity Scale (EWPS) |
44.7; 46.2; 33.3; 27.6; -9.7; -18.0 | 0.008 sig |
| SECONDARY Subject's Rating of Dyadic Satisfaction Subscale (DSS) |
32.3; 31.4; 32.5; 33.3; 0.0; 1.4 | 0.372 |
| SECONDARY Subject's Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication You Are Taking for ADHD? |
39; 14; 18; 17; 24; 7 | <0.001 sig |
| SECONDARY Responder Rate Using AISRS |
30.8; 45.0; 69.2; 55.0 | 0.008 sig |
| SECONDARY Clinical Global Impression - Severity of Illness Subscale (CGI-S) |
4.6; 4.7; 3.5; 3.0; -1.1; -1.7 | <0.001 sig |
| 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 |
29.9; 29.2; 27.3; 21.7; -1.7; -8.3 | 0.003 sig |
| SECONDARY Designated Observer's (DO) Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A) |
139.3; 144.1; 133.3; 127.3; -10.3; -20.1 | 0.016 sig |
| SECONDARY Designated Observer's (DO) Rating of Dyadic Satisfaction Subscale |
36.2; 35.8; 37.5; 37.2; 0.6; 1.5 | 0.092 |
| 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? |
5; 2; 4; 2; 8; 6 | 0.284 |
| SECONDARY Adult ADHD Self-Report Scale (ASRS) Over Time |
49.8; 51.6; 37.5; 32.6; -12.1; -19.4 | <0.001 sig |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) Total Score |
8.8; 9.1; 8.5; 8.4; -0.4; -0.8 | 0.319 |
| SECONDARY Epworth Sleepiness Scale (ESS) |
9.1; 9.5; 8.0; 7.0; -1.0; -2.5 | 0.007 sig |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00937040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.