EUCTR2005-004037-18-PT进行中（未招募）不适用
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
Janssen-Cilag EMEA0 个研究点目标入组 400 人开始时间: 2006年6月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
- •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
排除标准
- •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
- 另有 9 项未显示
研究者
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