Phase 4
Completed N=232
Stimulant Versus Nonstimulant Medication for Attention Deficit Hyperactivity Disorder in Children
Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT00183391 ↗
Enrolled (actual)
232
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcomePrimary: ADHD-RS Total Score — 39.58; 39.75; 20.03; 17.59 units on a scale
◆ Published Evidence
Established
62citations · ~6 / year
Differential impact of methylphenidate and atomoxetine on sustained attention in youth with attention-deficit/hyperactivity disorder.
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.
Linked Publications (2)
-
Differential impact of methylphenidate and atomoxetine on sustained attention in youth with attention-deficit/hyperactivity disorder.
-
Striatal Activation Predicts Differential Therapeutic Responses to Methylphenidate and Atomoxetine.
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 |
— | — |
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) and the linked publication. 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.