Phase 3
N=64
Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR
Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00393042 ↗Enrolled (actual)
64
Serious AEs
0.3%
Results posted
Apr 2017
Primary outcome: Primary: Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. — 2249; 2304; 2319; 2325 HHMM.SS
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexmethylphenidate (Drug); Mixed Amphetamine Salts, ER (Drug); placebo (Drug)
- Age
- Pediatric · 9+ yrs
- Sex
- All
- Sponsor
- Seattle Children's Hospital
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. |
2249; 2304; 2319; 2325; 2309; 2309 | — |
| PRIMARY Sleep Duration |
459.6; 446.7; 432.17; 425.5; 438.82; 443.2 | — |
| SECONDARY ADHD Parent Rating Scale-IV |
16.61; 6.40; 12.2; 12.74; 17.31; 17.51 | — |
| SECONDARY Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms |
18.60; 18.83; 19.00; 15.40; 19.33; 22.20 | — |
| SECONDARY Clinical Global Impression - Severity |
4.26; 4.09; 3.48; 3.56; 4.24; 4.24 | — |
| SECONDARY Weiss Functional Impairment Rating Scale (WFIRS) |
6.72; 7.02; 6.35; 6.70; 7.39; 7.35 | — |
Summary
The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in sleep and other side effects, such as changes in mood or loss of appetite, which can occur with stimulant medications. A third purpose is to determine if there are differences in the characteristics of individuals who respond better to either of the medications.
This research is being done because the investigators do not know if one of these two commonly used treatments is better tolerated than the other. Children and adolescents with ADHD often have a hard time sitting still, playing quietly, finishing things they start, paying attention, waiting their turn, and not distracting others. These medications improve these symptoms, but sometimes affect sleep, appetite, or mood.
It is hypothesized that at effective and frequently prescribed doses, Adderall will be associated with insomnia, more stimulant side effects, and decreased tolerability during an acute trial relative to Focalin.
Eligibility Criteria
Inclusion Criteria
- Any ADHD subtype, determined by KSADS interview (Kaufman, Birmaher et al. 1997). Comorbidity will likewise be allowed, to ensure representation.
- Signed informed consent and assent
- Clinical Global Impressions - Severity for ADHD (CGI-S-ADHD) rating is greater than or equal to 4
- Findings on physical exam, laboratory studies, vital signs, and ECG are judged to be normal for age
- Pulse and blood pressure are within 95% of age and gender mean
- Able to complete study instruments and swallow capsules
- Willing to commit to the entire visit schedule for the study, including at least one visit to UIC Medical Center.
Exclusion Criteria
- Previous diagnosis of mental retardation
- Non-responder to either medication at the doses offered in the study in an adequate trial
- Must not have experienced disabling adverse effects with either medication
- Concomitant psychotropic medications are required or medications which might have a CNS effect
- Any other medical condition which represents a contraindication for either treatment is present
- History of alcohol or drug abuse in the past 3 months, or a positive urinary toxic screen on initial evaluation that is not explained by a time-limited medical circumstance
- Females of childbearing age who are sexually active, do not use acceptable birth control (double protection method), and after counseling, are unwilling to do so
- History of allergic reactions to multiple medications
- A history of psychosis
- Diagnosis of bipolar disorder
Data sourced from ClinicalTrials.gov (NCT00393042). 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.