Study of the Long-Term Impact on Functioning using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Treatment-Naïve Children and Adolescents.
- Conditions
- Attention-Deficit/HyperactivityDisorder (ADHD)MedDRA version: 14.1Level: LLTClassification code 10003735Term: Attention deficit-hyperactivity disorderSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2006-005512-27-ES
- Lead Sponsor
- illy S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
[1] Patients must be at least 6 years of age, but must not have reached their 17th birthday at Visit 1.
[2] Patients must meet the Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition Text Revision? (DSM-IV-TR?) diagnostic criteria for ADHD. For the purposes of this study the diagnosis of ADHD will be confirmed during Visit 1 by
administering the K-SADS-PL. Patients must also have an ADHDRS- IV Parent:Inv score at least 1.5 standard deviations above the age norm for their diagnostic subtype at both Visit 1 and Visit 2. In
addition, they must have a CGI-ADHD-S score ?4 at both Visit 1 and Visit 2.
[3] Patients must be pharmacological naive at Visit 1. Pharmacological naive is defined as not having received more than seven consecutive days of any dose of pharmacotherapy for ADHD during the
patient?s lifetime and having not received more than two consecutive days of any dose of pharmacotherapy for ADHD within
30 days before Visit 1.
[4] Patients must be able to swallow capsules.
[5] Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence
and likely, in the investigator?s judgment, to achieve a score of ?80 on an IQ test). The administration of a formal IQ test is not an entry requirement for this study. Specific learning disabilities are not considered general impairments of intelligence.
[6] Patients and parents/legal guardians have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
[7] Patients and parents must be able to communicate adequately with the investigator and site personnel.
[8] This inclusion criterion applies to females of child-bearing potential
only.
Test negative for pregnancy at the time of entry (Visit 1) based on a urine pregnancy test. If local law, an ERB and/or regulatory bodies have different requirements then these requirements take precedence.
[9] Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an ICD.
Are the trial subjects under 18? yes
Number of subjects for this age range: 400
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
[10] Patients who weigh less than 20 kg at study entry (Visit 1).
[11] Patients who have a documented history of bipolar disorder, any history of psychosis or pervasive development disorder (autistic spectrum disorder). If the investigator believes that such a diagnosis
has previously been made in error, he/she should contact Lilly and discuss the case history with the Lilly physician responsible for the study prior to allowing the patient to enter the study.
[12] Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control are not eligible to participate.
[13] Patients at serious suicidal risk as assessed by the investigator.
[14] Patients with a history of alcohol or drug abuse within the past 3 months, or who are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner which
the investigator considers indicative of abuse
[15] Patients with significant prior or current medical conditions, surgically
corrected congenital heart defects, or malignancy.
[16] Patients who have a medical condition that would increase sympathetic nervous system activity markedly or who are taking a medication on a daily basis that has
sympathomimetic activity. Such medications can be taken on an occasional basis.
[17] Patients with a history of hyperthyroidism or hypothyroidism will be
excluded. However, patients who were previously diagnosed with hyperthyroidism or hypothyroidism, who have been treated with a stable dose of thyroid supplement for at least the past 3 months, and who are
clinically and chemically euthyroid will be allowed to participate in the study.
[18] Patients with acute closed angle glaucoma.
[19] Use of monoamine oxidase inhibitors (MAOIs) during the 2 weeks (14 days) prior to Visit 2.
[20] Current or past history of hypertension. For the purposes of this protocol, hypertension will be defined as average systolic or diastolic blood pressure
measured on at least 2 separate occasions, greater than or equal to the 95th percentile for age and sex defined by the National Heart and Lung Institute (National High Blood Pressure Education Program Working Group on Hypertension Control in Children and Adolescents 1996). The accuracy of
historical diagnoses will be determined by the investigator.
[21] Patients with cardiovascular disease, prolonged QT interval or other conditions that could be aggravated by an increased heart rate or increased blood pressure.
[22] Pregnant or breastfeeding females are excluded from the study.
[23] Sexually active females who do not use a medically acceptable method of contraception are also excluded from the study. For this study, medically acceptable methods of contraception include barrier methods (condom or diaphragm with spermicidal agent) or oral contraception. The rhythm method (abstinence during predicted times of ovulation with unprotected intercourse at other times) or
coitus interruptus prior to ejaculation by the male partner are not acceptable means of contraception.
[24] Patients with a history of severe allergies to more than one class of
medications or have had multiple adverse drug reactions.
[25] Patients who at any time during the study period II are likely to begin a structured psychotherapy aimed at ADHD. Psychotherapy initiated at least 1 month prior to study participation is acceptable;
however during study period II, after study participatio
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method