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Clinical Trials/EUCTR2005-004037-18-ES
EUCTR2005-004037-18-ES
Active, not recruiting
Not Applicable

An Open Label, Multicentre 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 - Lamda extension

Janssen-Cilag Medical Affairs EMEA0 sites250 target enrollmentDecember 21, 2005
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ConditionsAttention Deficit-Hyperactivity Disorder (ADHD)MedDRA version: 7.1Level: LLTClassification code 10003735
DrugsCONCERTA 18 mg comprimidos de liberación prolongadaCONCERTA 36 mg comprimidos de liberación prolongadaCONCERTA 54 mg comprimidos de liberación prolongada

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attention Deficit-Hyperactivity Disorder (ADHD)
Sponsor
Janssen-Cilag Medical Affairs EMEA
Enrollment
250
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 21, 2005
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Janssen-Cilag Medical Affairs EMEA

Eligibility Criteria

Inclusion Criteria

  • •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 Statiscal 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.

Exclusion Criteria

  • •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 obsessive\-compulsive 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.

Outcomes

Primary Outcomes

Not specified

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