Study to Evaluate the Efficacy and Quality of Life of Long-Acting Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

NCT ID: NCT00783835

Last Updated: 2013-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2008-10-31

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methylphenidate

Group Type: EXPERIMENTAL

Long-Acting Methylphenidate

Intervention Type: DRUG

Long-Acting Methylphenidate within the range of 18, 36, 54 and 76 milligram will be orally administered once daily up to Day 56.

Interventions

Long-Acting Methylphenidate

Long-Acting Methylphenidate within the range of 18, 36, 54 and 76 milligram will be orally administered once daily up to Day 56.

Intervention Type: DRUG

Other Intervention Names

Concerta

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag Farmaceutica Ltda.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag Farmaceutica Ltda. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Farmaceutica Ltda.

Locations

Belo Horizonte, , Brazil

Porto Alegre, , Brazil

Rio de Janeiro, , Brazil

Salvador, , Brazil

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

42603ATT4053

Identifier Type: -

Identifier Source: secondary_id

NCT00783835

Identifier Type: -

Identifier Source: secondary_id

CR013999

Identifier Type: -

Identifier Source: org_study_id