A randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of Ritalin® LA in adult patients with childhood-onset ADHD

• Conditions: Adult patients with childhood-onset Attention Deficit Hyperactivity Disorder; MedDRA version: 12.1Level: LLTClassification code 10003737Term: Attention deficit/hyperactivity disorder NOS; MedDRA version: 12.1Level: LLTClassification code 10003735Term: Attention deficit-hyperactivity disorder; MedDRA version: 12.1Level: LLTClassification code 10003736Term: Attention deficit/hyperactivity disorder; MedDRA version: 12.1Level: PTClassification code 10003736Term: Attention deficit/hyperactivity disorder

• Registration Number: EUCTR2010-021533-31-DK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-03
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1.Written informed consent must be obtained before any assessment is performed.
2.Patients must be capable of complying with study procedures.
3.Male or female adults from 18-60 years of age.
4.Diagnosis of Attention-Deficit /Hyperactivity Disorder (ADHD) all types with a confirmed childhood onset according to DSM-IV diagnostic criteria.
5.DSM-IV ADHD Rating Scale total score greater than or equal to 30 at Screening and Baseline.
6.Female patients of childbearing potential must be practicing an acceptable method of contraception. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

Exclusion Criteria

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
1.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
2.History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
3.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
4.Patients with a BMI < 18.5 kg/m2 or > 35 kg/m2
5.Patients who demonstrate a 30% or greater improvement in the DSM-IV ADHD RS total score at Baseline relative to the score obtained at the Screening Visit.
6.History of alcohol or substance abuse or dependence within the last six months.
7.History of seizures or use of anticonvulsant medication for seizure control (except childhood febrile seizures).
8. Any psychiatric condition, including anxiety, tension, agitation, aggressive behavior, psychotic symptoms, suicidal tendency, that requires treatment with medication or that, in the judgment of the investigator, may interfere with study participation and /or study assessments.
9. Pre-existing cardiovascular disorders including severe hypertension, angina, arterial occlusive disease; heart failure, hemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels).
10. Evidence upon physical examination or history of any clinically significant respiratory, hepatic, gastrointestinal, renal, hematological, or oncologic disorder requiring current medical intervention/therapy or likely to have a significant impact on the outcome of this study.
11. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma.
12. Diagnosis or family history of Tourette’s syndrome.
13. Patients receiving any psychotropic medications. The minimum discontinuation period varies according to drug class follows:
•One week prior to the Screening Visit: stimulants including MPH, antidepressants other than fluoxetine, antipsychotics, anticonvulsants for non-epilepsy uses, mood-stabilizing medications such as lithium, and herbal preparations with psychotropic potential.
•Two weeks prior to the Screening Visit: benzodiazepines, barbiturates, all other sedatives or hypnotics, and monoamine oxidase inhibitors (MAOIs).
•Four weeks prior to the Screening Visit: Fluoxetine.
14. Patients receiving any psychological or behavioral therapies for the treatment of ADHD. Such therapies must be discontinued at least one month prior to the Screening Visit.
15. Patients who have initiated any psychological or behavioral therapies for reasons other than ADHD within three months prior to the Screening Visit. If it has been ongoing for at least three months with the same therapist, the patient may be eligible to enter the study provided that it is continued throughout the study.
16. Patients who, in the investigator’s judgment, have a history of poor response or intolerance to stimulants (e.g. methylphenidate, dexmethylphenidate, amphetamine salts, dextroamphetamine salts).
No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified