Study to Evaluate the Efficacy and Quality of Life of Long-Acting Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Registration Number
- NCT00783835
- Lead Sponsor
- Janssen-Cilag Farmaceutica Ltda.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Methylphenidate Long-Acting Methylphenidate -
- Primary Outcome Measures
Name Time Method Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4 Baseline and 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).
Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8 Baseline and 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).
Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12 Baseline and 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).
Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4 Baseline and 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.
Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12 Baseline and 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.
- Secondary Outcome Measures
Name Time Method 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 The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 = "Normal, not at all ill" and a rating of 7 = "Among the most extremely ill participants". Higher scores indicate worsening.
Clinical Global Impression-Improvement (CGI-I) Score Week 4, 8 and 12 The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse).
Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale Baseline, Week 4, 8 and 12 The STAI scale consists of total 40 items on separate scales measuring state (20 items) and trait (20 items) anxiety. The participant reports how they feel right now at this moment for state anxiety and how they generally feel for trait anxiety. The state items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The trait items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). The total scores range from 4-80 for each scale. Higher scores indicate more impaired participants.
Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12 Screening (Week -2), 4 and 12 It is a 21-item clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. 11 items are scored on a 3 point scale (0=none/absent to 2=most severe), 2 items are scored on a 4 point scale (0=none/absent to 3=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe). The individual items are summed to yield the HAM-D total score that ranges from 0-60, where higher scores indicate worsening.