Phase 4
N=232
Stimulant Versus Nonstimulant Medication for Attention Deficit Hyperactivity Disorder in Children
Attention Deficit Disorder With Hyperactivity
Bottom Line
View on ClinicalTrials.gov: NCT00183391 ↗Enrolled (actual)
232
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: ADHD-RS Total Score — 39.58; 39.75; 20.03; 17.59 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atomoxetine (Drug); Methylphenidate (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ADHD-RS Total Score |
39.58; 39.75; 20.03; 17.59; 34.32; 33.54 | — |
| SECONDARY Treatment Preference Survey |
41.8; 27.4; 50.5; 51.9 | — |
| SECONDARY ADHD - H/I |
16.56; 17.31; 7.82; 7.24; 13.99; 14.80 | — |
| SECONDARY ADHD-RS Inattention |
23.30; 22.44; 12.32; 10.35; 20.33; 18.74 | — |
| SECONDARY Clinical Global Impressions (CGI)- Severity |
5.14; 5.09; 3.20; 2.83; 4.75; 4.55 | — |
| SECONDARY Social Skills Rating Scale (SSRS)- Parent Version |
82.71; 77.96; 91.07; 88.57; 78.58; 82.35 | — |
| SECONDARY Child Conflict Index (CCI) |
.3224; .3385; .2386; .1978; .3526; .3078 | — |
| SECONDARY Continuous Performance Test (CPT) |
51.3277; 52.8976; 51.7005; 51.1713; 59.8788; 51.2159 | — |
| SECONDARY Children's Sleep Questionnaire |
5.14; 5.09; 3.20; 2.83; 4.75; 4.55 | — |
| SECONDARY Assessment of Affective Range (AAR) |
11.2609; 10.6905; 10.6889; 10.8257; 9.7108; 10.1400 | — |
| SECONDARY Tics: Total Motor |
.196; .111; .053; 1.342; .000; .214 | — |
| SECONDARY Tics: Total Phonic |
.161; .028; .018; 1.329; .039; .057 | — |
| SECONDARY Tics: Total Impairment |
5.304; .292; 1.737; .132; .000; .643 | — |
| SECONDARY Vital Signs - Systolic Blood Pressure |
101.11; 101.60; 102.10; 103.29; 99.74; 101.29 | — |
| SECONDARY Vital Signs - Diastolic Blood Pressure |
61.78; 61.26; 64.58; 62.77; 62.33; 61.28 | — |
| SECONDARY Vital Signs - Pulse |
78.20; 77.49; 84.46; 82.05; 82.96; 81.30 | — |
| SECONDARY SES (Hollingshead) |
— | — |
| SECONDARY Conners-Wells Adolescent Self Report |
— | — |
| SECONDARY Conners Teacher Rating Scale- Short |
— | — |
| SECONDARY Child Behavior Checklist (CBCL) |
— | — |
| SECONDARY Social Skills Rating Scale (SSRS)- Teacher Version |
— | — |
| SECONDARY Permanent Mathematics Product Test (PERMP) |
— | — |
| SECONDARY Actigraphy |
— | — |
| SECONDARY Sleep Logs |
— | — |
| SECONDARY Hyperactivity, Attention, and Learning Problems (HALP) Medical and Developmental History Questionnaire |
— | — |
| SECONDARY HALP Rebound Effects Questionnaire |
— | — |
Summary
This study will determine the effectiveness of stimulant and nonstimulant medication in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in children and adolescents.
Eligibility Criteria
Inclusion Criteria
- Meets DSM-IV-TR criteria for ADHD
- Scores at least 1.5 standard deviation higher than age and gender mean on ADHD-RS keyed to ADHD subtype
- CGI Severity ADHD Rating greater than or equal to 4
- Currently attends school with at least 3 months left in high school
- Currently lives at home with parent(s) or legal guardian(s), now and for the past year before study entry, and is expected to remain there
- Normal physical exam, laboratory tests, and electrocardiogram
- Pulse and blood pressure within 95% of age and gender mean
- Full Scale IQ is greater than or equal to 75 OR if the results of testing indicate that Full Scale IQ is not a good indicator of intellectual ability, a General Ability Index greater than or equal to 75
- Weight is between 20 and 85 kilograms
- Able to swallow pills
- Parent or guardian willing to provide informed consent
Exclusion Criteria
- History of atomoxetine or methylphenidate intolerance
- Any existing medical condition for which study medications are contraindicated
- If the child is in psychotherapy, no changes in therapy expected during the study trial
- Presence of any of the following: autism, mental retardation, schizophrenia, a psychotic disorder, bipolar disorder, severe depression, or conduct disorder
- Presence of a comorbid disorder that should be the primary focus of treatment
- Presence of a medical or neurological disorder precluding study medications or assessing ADHD
- Allergic reactions to multiple medications
- History of alcohol or drug abuse in the 3 months before study entry, or positive urine toxic screen that is not explained by a time limited medical circumstance
- Involved in a medication treatment study in the 30 days before study entry
- Female who is sexually active and is unwilling to use birth control
- Evidence of child abuse or neglect
Data sourced from ClinicalTrials.gov (NCT00183391). 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.