ADHD
Conditions
Keywords
cigarette smoking, ADHD, adolescents, Concerta
Brief summary
This study will consist of a six-week open-label treatment period with an extended duration methylphenidate (OROS MPH) followed by subsequent monthly visits for 24 months in a large sample of youths aged 12-17 who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD. The researchers hypothesize that OROS MPH treatment will be associated with low rates of cigarette smoking in ADHD youth.
Interventions
OROS MPH will be openly prescribed to a maximum of 1.5 mg/kg/day (maximum 126 mg/day). Doses will be titrated according to clinical assessment of efficacy and tolerability.
Sponsors
Ortho-McNeil Janssen Scientific Affairs, LLC
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Adolescent outpatients between 12 to 17 years of age (inclusive). 2. Subjects with the DSM-IV diagnosis of ADHD, as manifested in the clinical evaluation and confirmed by structured interview. 3. Subjects with sufficient current ADHD symptoms to warrant treatment, as measured by a Clinical Global Impression Severity Scale (CGI-S) score of greater than or equal to 4 (moderately ill); OR subjects already on Concerta who are judged to be responders (CGI of 1 or 2) and who tolerate treatment well.
Exclusion criteria
1. Any serious or unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, hypertension), endocrinologic, neurologic, immunologic, or hematologic disease. 2. Clinically significant abnormal baseline laboratory values 3. History of seizures 4. Active tic disorder 5. Pregnant or nursing females 6. Mental retardation (intelligence quotient \[IQ\] \< 75) 7. Organic brain disorder 8. Eating disorders 9. Psychosis 10. Current bipolar disorder (current episode) 11. Current depression \> mild (CGI-S \> 3) 12. Current anxiety \> mild (CGI-S \> 3) 13. Substance abuse or dependence within the past 2 months 14. Recent change in non-monoamine oxidase inhibitor (MAOI) antidepressants (\< 3 months) 15. Recent change in benzodiazepines (\< 3 months) 16. Concerta non-responder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarette Smoking | 24 months | Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OROS-Methylphenidate Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH. | 154 |
| Total | 154 |
Baseline characteristics
| Characteristic | OROS-Methylphenidate |
|---|---|
| Age, Categorical <=18 years | 154 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 15.3 years STANDARD_DEVIATION 1.8 |
| Region of Enrollment United States | 154 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 45 / 154 |
| serious Total, serious adverse events | 5 / 154 |
Outcome results
Primary
Cigarette Smoking
Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)
Time frame: 24 months
Population: Clinical trial subjects included in this analysis included those adolescents who took at least one dose of OROS MPH following baseline assessment (N=154), with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule of 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OROS-Methylphenidate | Cigarette Smoking | 7 percent |