An Open Label, Multicenter Study to Evaluate the Long Term Safety of Prolonged Release (PR) OROS Methylphenidate (18, 36, 54, 72 and 90 mg/day) in Adults with Attention Deficit/Hyperactivity Disorder
- Conditions
- Attention Deficit/Hyperactivity DisorderMedDRA version: 8.0Level: LLTClassification code 10003733
- Registration Number
- EUCTR2005-004037-18-PT
- Lead Sponsor
- Janssen-Cilag EMEA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Subjects must satisfy the following criteria to be enrolled in the study:
1. Subjects can be male or female.
2. Age must be aged between 18 and 65 years, inclusive.
3. Diagnosis of ADHD according to the Diagnostic and Statistical Manual
of Mental Diseases, Fourth Edition (DSM-IV)1,32 and confirmed by the
Conners’ Adult ADHD Diagnostic Interview for DSM-IV.
4. Described chronic course of ADHD symptomatology from childhood to
adulthood, with some symptoms present before age 7 years and continue
to meet DSM-IV criteria at the time of assessment. ADHD is not
diagnosed if the symptoms are better accounted for by another
psychiatric disorder (e.g. mood disorder (especially bipolar disorder),
anxiety disorder, psychotic disorder, personality disorder).
5. Completion of the open label phase in the 42603ATT3002 trial
according to protocol.
6. Female subjects of child-bearing potential must agree to use an
acceptable form of contraception (e.g., prescription oral contraceptives,
contraceptive injections, intrauterine device, double-barrier method,
contraceptive patch, male partner sterilisation) before entry and throughout the study, and must have a negative urine pregnancy test at
screening.
7. Informed Consent Form signed by the subject.
8. Subject agrees to take only the supplied study drug as treatment for
ADHD during the study.
9. Subject agrees not to initiate a new behavioural modification
programme during the study or if currently using a behavioural
modification programme and agrees not to change this programme
during the study.
10. Subject is able to comply with the study visit schedule and willing and
able to complete the protocol-specified assessments.
11. Healthy on the basis of a physical examination, medical history and
anamnesis.
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
Potential subjects who meet any of the following criteria will be excluded
from participating in the study:
1. Known to be a non-responder to methylphenidate, or subject has a child
known to be a non-responder to methylphenidate.
2. Known allergy or hypersensitivity to methylphenidate, or components of
PR OROS methylphenidate.
3. Has been treated with any methylphenidate-containing medication
within 1 month of screening visit, except trial medication provided in
42603ATT3002 trial
4. Any clinically unstable psychiatric condition including but not limited to
the following: acute mood disorder, bipolar disorder, acute obsessivecompulsive
disorder (OCD), anti-social personality disorder, borderline
personality disorder.
5. Subjects with a family history of schizophrenia or family history of
affective psychosis.
6. Autism or Asperger’s syndrome.
7. Subjects with presence of motor tics, history of Tourette’s syndrome or
family history of Tourette’s syndrome.
8. A diagnosis of substance use disorder (abuse/dependence) according to
DSM-IV criteria within 6 months prior to screening evaluation (nicotine
and caffeine dependence are not exclusionary). Episodic abuse in the
past is not an exclusion criterion.
9. Current eating disorder (e.g. bulimia, anorexia nervosa) or history of an
eating disorder.
10. Known or suspected mental retardation.
11. Hyperthyroidism, myocardial infarction or stroke in the 6 months prior
to screening for this study.
12. Subjects with history of seizures, glaucoma or uncontrolled
hypertension.
13. Subjects with angina pectoris or cardiac arrhythmias
14. Pregnant or breast-feeding females.
15. Any co-existing medical condition or taking any concomitant
medication that is likely to interfere with safe administration of
methylphenidate including any herbal or homeopathic remedies; herbal
and over-the-counter weight loss or diet preparations or drugs that
contain stimulants.
16. Use of monoamine oxidase inhibitors.
17. Use of other anti-depressants (unless subject has been on a stable
dosage during the 42603ATT3002 trial, in which case treatment may
continue so long as dosage remains unchanged for the duration of the
study) or mood stabilisers (e.g. anti-epileptics, lithium. Any medication
likely to interfere with safe administration of methylphenidate.
18. Use of clonidine or other alpha-2 adrenergic receptor agonists,
antipsychotic medications, theophylline, coumarin anticoagulants,
anticonvulsants.
19. Subjects who have clinically significant gastrointestinal problems,
including severe narrowing (pathologic or iatrogenic) of the
gastrointestinal tract.
20. Subjects who are unable to swallow the study medication whole with the
aid of liquids (participants may not chew, divide, dissolve or crush the
study medication).
21. History of severe drug allergy or hypersensitivity.
22. Any serious illnesses including, but not limited to liver or renal
insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal,
endocrine, neurological, psychiatric or metabolic disturbances.
23. Confirmed cancer or malignancy.
24. Employee of the investigator or the institution who have direct
involvement in the trial or other trials under the direction of the
investigator or their members.
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