Clinical trial NCT00783835: Study to Evaluate the Efficacy and Quality of Life of Long-Acting Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: A Multicenter Open Trial to Evaluate the Effectiveness and Quality of Life in Adults With Attention Deficit /Hyperactivity Disorder (ADHD) Treated With Long Acting Methylphenidate (CONCERTA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Methylphenidate
Concerta
CONQoL
Lead sponsor: Janssen-Cilag Farmaceutica Ltda.
Sponsor class: INDUSTRY
First posted: 2008-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety and to assess the impact of the treatment on quality of life of long-acting methylphenidate in adult participants with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a clinical condition beginning in childhood and is characterized by inadequate levels of attention, hyperactivity and impulsiveness.

Detailed description: This is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), single arm study of multiple doses of long-acting methylphenidate in participants with ADHD. The study will consist of 2 phases; a screening phase and a treatment phase. The duration of participation in the study for an individual participant will be up to 12 weeks. Participants will be given 18 milligram (mg) of long-acting methylphenidate daily in the morning and titrated up (slow increase in drug dosage guided by participant's responses) to 36 mg per day (mg/day) on Day 8. Depending on response, tolerability and clinician's judgment, the dose could be escalated to the next dose level of 54 mg/day on Day 28 to a maximum of 72 mg/day on Day 56, until each participant achieved optimal dose. Participant's safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria

* Diagnosis of Attention Deficient Hyperactivity Disorder (ADHD) according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV), obtained via interview with an adapted version of the Kiddie-Schedule of Affective Disorders and Schizophrenia-Epidemiologic Version (K-SADS E) module for ADHD
* Described chronic course of ADHD symptomatology from childhood to adulthood, with some symptoms present before age 7 years, which 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 \[e.g. mood disorder (especially bipolar disorder), anxiety disorder, psychotic disorder, personality disorder\]
* Clinical Global Impression-Severity (CGI-Severity) baseline score greater than or equal to (\>=) 4 (at least moderate severity)
* Female participants must be postmenopausal (after the time in life when a woman stops having a menstrual period) for at least 1year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives\[compounds, usually hormonal, taken orally in order to block ovulation and prevent the occurrence of pregnancy\], contraceptive injections \[chemical substances that prevent or reduce the probability of pregnancy\], intrauterine device \[contraceptive devices placed high in the uterine fundus\], double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; have a negative urine pregnancy test at baseline
* Participant agrees to take only the supplied study drug as treatment for ADHD during the study

Exclusion Criteria

* Participant having allergy or hypersensitivity to methylphenidate
* Participants who are non-responder to methylphenidate in adequate doses (i.e., 0.8 - 1.0 milligram per kilogram \[mg/kg\])
* Participant treated with any methylphenidate or amphetamine containing medication within 4 weeks of the screening visit
* Participant having Hamilton's Depression Scale, suicide item higher than 2
* Participant having any psychiatric condition including the following, but not limited to: acute mood disorder (disorders that have a disturbance in mood as their main feature), schizophrenia (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder), bipolar disorder I (disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission \[when a medical problem gets better or goes away at least for a while\] and recurrence \[happen again\]), obsessive compulsive disorder (OCD) (an anxiety disorder characterized by recurrent, persistent obsessions or compulsions, anti-social personality disorder ( personality disorder whose essential feature is a pervasive pattern of disregard for, and violation of, the rights of others that begins in childhood or early adolescence and continues into adulthood)

Primary outcomes:
measure: Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8
timeFrame: Baseline and Week 8
measure: Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12
timeFrame: Screening (Week -2), 4, 8 and 12
measure: Clinical Global Impression-Improvement (CGI-I) Score
timeFrame: Week 4, 8 and 12
measure: Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale
timeFrame: Baseline, Week 4, 8 and 12
measure: Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12
timeFrame: Screening (Week -2), 4 and 12
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
city: Porto Alegre
country: Brazil
city: Rio De Janeiro
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
Study officials:
affiliation: Janssen-Cilag Farmaceutica Ltda.
name: Janssen-Cilag Farmaceutica Ltda. Clinical Trial
role: STUDY_DIRECTOR
References: