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

NCT00783835 | Completed Phase 4 Results

• 3 other identifiers: CR01399942603ATT4053NCT00783835
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; Methylphenidate; Concerta; CONQoL

Outcome Measures

Primary Outcomes (5)

• Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4

  Adult ASRS assesses 18 core ADHD symptoms corresponding to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).

  Baseline and Week 4

• Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8

  Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).

  Baseline and Week 8

• Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12

  Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).

  Baseline and Week 12

• Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4

  The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.

  Baseline and Week 4

• Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12

  The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.

  Baseline and Week 12

Secondary Outcomes (4)

• Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12

  Screening (Week -2), 4, 8 and 12

• Clinical Global Impression-Improvement (CGI-I) Score

  Week 4, 8 and 12

• Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale

  Baseline, Week 4, 8 and 12

• Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12

  Screening (Week -2), 4 and 12

Study Arms (1)

Methylphenidate

EXPERIMENTAL

Drug: Long-Acting Methylphenidate

Interventions

Long-Acting Methylphenidate DRUG

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

Also known as: Concerta

Methylphenidate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen-Cilag Farmaceutica Ltda.: lead

Study Sites (5)

Unknown Facility

Belo Horizonte, Brazil

Location

Unknown Facility

Porto Alegre, Brazil

Location

Unknown Facility

Rio de Janeiro, Brazil

Location

Unknown Facility

Salvador, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Manager
• Organization: Janssen-Cilag Farmaceutica Ltda

+55 11 30302738

Study Officials

• Janssen-Cilag Farmaceutica Ltda. Clinical Trial

  Janssen-Cilag Farmaceutica Ltda.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2008
• First Posted: November 3, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: July 23, 2013
• Results First Posted: July 23, 2013

Record last verified: 2013-07

Locations

BR (5)