Clinical trial NCT01127646: A Study in Attention Deficit Hyperactivity Disorder in Children and Adolescents
Official title: Assessing the Effect of Missing Doses (Off-Days) of Daily Medication in Patients Stable on Pharmacotherapy for ADHD Receiving Atomoxetine or OROS Methylphenidate: A Parallel Matched Group Clinical Study (On/Off Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-05-21
Enrollment: 23
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of the study is to help to understand the effect on children and adolescents who are stable on treatment with atomoxetine or osmotic-release oral system (OROS) methylphenidate for attention-deficit/hyperactivity disorder (ADHD) of not taking the medication for a maximum of 6 days over a 28-day study treatment period.

Detailed description: The present study is designed to assess the effect of missed doses of daily medication (off-days). On the off-days the patient will take a placebo (sugar pill). Over the 4 weeks of the actual study there will be 6 random off-days of study medicine and neither the caregiver, patient nor study doctor will know which days are the missing days.

To cover all aspects of the patients' lives and notably their school time, aside from investigator's assessments, evaluations will also be performed on a daily basis by those involved in their day-to-day life: parents, teachers (on school days) and the patients themselves, using an electronic diary.

Eligibility criteria: Inclusion Criteria:

* Patients must meet the Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition Text Revision (DSM-IV-TR) diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD), confirmed at screening by administering the Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version.
* Patients must have an Attention-Deficit/Hyperactivity Disorder Rating Scale - IV - Parent Version: Investigator Administered and Scored, total score of less than or equal to 20 at screening and baseline.
* Patients must have a Clinical Global Impression-Attention-Deficit/Hyperactivity Disorder-Improvement score of 1 ("very much better") or 2 ("much better") at screening and baseline.
* Patients must have been taking either atomoxetine or osmotic-release oral system methylphenidate for the treatment of ADHD between 3 and a maximum of 15 months prior to screening.
* Patients must have been receiving the same dose of atomoxetine or osmotic-release oral system methylphenidate as monotherapy in a single daily dose during the 4 weeks prior to screening.
* For females of child-bearing potential only: Test negative for pregnancy at the time of entry based on a urine pregnancy test
* Signed informed consent document (ICD)

Exclusion Criteria:

* Patients who weigh less than 20 kilograms (kg) or more than 70 kg at study entry
* Documented history of bipolar disorder, any history of psychosis or pervasive development disorder.
* Patients with a history of any seizure disorder or patients who have taken anticonvulsant treatment for seizure control.
* Patients at serious suicidal risk.
* History of severe allergies to more than one class of medications or have had multiple adverse drug reactions.
* Patients with acute or unstable medical conditions including cardiovascular disease and hypertension.
* Patients taking excluded concomitant medications or likely to begin structured psychotherapy for ADHD.
* Patients who are currently enrolled in, or discontinued within the last 30 days from a clinical trial.
* Sexually active females who do not use a medically acceptable method of contraception.

Primary outcomes:
measure: Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Mean Total Score (On-Days Versus Off-Days) During the 4-Week Treatment Period
timeFrame: Baseline through 4 weeks
Secondary outcomes:
measure: Global Impression of Perceived Difficulties (GIPD) Scale-Patient Version Total Score and Individual Items (On-Days Versus Off-Days) During the 4-Week Treatment Period
timeFrame: Baseline through 4 weeks
measure: Conners' Global Index-Teacher Rating Scale Total Score (On-Days Versus Off-Days) During the 4-Week Treatment Period
timeFrame: Baseline through 4 weeks
measure: Global Impression of Perceived Difficulties Scale-Patient Version (GIPD-Pat) Scale Total Score and Individual Items During the 4-Week Treatment Period
timeFrame: Baseline through 4 weeks
measure: Attention-Deficit/Hyperactivity Disorder Rating Scale-Parent Version: Investigator Administered and Scored (ADHD-RS-IV Parent:Inv) Total Score and Subscores at Weeks 2, 3, and 4
timeFrame: Weeks 2, 3, and 4
measure: Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) at Weeks 2, 3, and 4
timeFrame: Weeks 2, 3, and 4
measure: Emotion Expression Scale for Children (EESC)-Parent Rated Total Score up to Week 5
timeFrame: Up to Week 5
measure: Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Subscores (On-Days Versus Off-Days) During the 4-Week Treatment Period
timeFrame: Baseline through 4 weeks
measure: Patient Outcomes Questions (On-Days Versus Off-Days) During the 4-Week Treatment Period
timeFrame: Baseline through 4 weeks
measure: Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Total Score and Subscores During the 4-Week Treatment Period
timeFrame: Baseline through 4 weeks
measure: Conners' Global Index-Teacher Rating Scale Total Score During the 4-Week Treatment Period
timeFrame: Baseline through 4 weeks
measure: Global Impression of Perceived Difficulties Investigator Version (GIPD-Inv) Total Score and Subscores At Weeks 2, 3, and 4
timeFrame: Weeks 2, 3, and 4
Other outcomes:
measure: Change From Baseline in Heart Rate up to 5 Weeks
timeFrame: Baseline, up to 5 weeks
measure: Change From Baseline in Systolic and Diastolic Blood Pressure up to 5 Weeks
timeFrame: Baseline, up to 5 weeks
Locations:
city: Arnhem
country: Netherlands
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Capelle Aan Den Ijssel
country: Netherlands
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Maastricht
country: Netherlands
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Rotterdam
country: Netherlands
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Barcelona
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Esplugues De Llobregat
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Palma De Mallorca
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Sabadell
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: San Sebastian
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Göteborg
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Handen
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Malmo
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Stockholm
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Uppsala
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: