Phase 4
N=60
Study to Evaluate the Efficacy and Quality of Life of Long-Acting Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00783835 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4 — 52.6; -10.9 Unit on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Long-Acting Methylphenidate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen-Cilag Farmaceutica Ltda.
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4 |
52.6; -10.9 | — |
| PRIMARY Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8 |
-16.2 | — |
| PRIMARY Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12 |
-20.6 | — |
| PRIMARY Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4 |
39.6; 19.4 | — |
| PRIMARY Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12 |
21.9 | — |
| SECONDARY Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12 |
4.6; -1.0; -1.3; -1.7 | — |
| SECONDARY Clinical Global Impression-Improvement (CGI-I) Score |
2.7; 2.4; 2.2 | — |
| SECONDARY Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale |
50.4; 52.7; -6.1; -8.4; -7.8; -8.4 | — |
| SECONDARY Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12 |
5.9; -2.8; -3.3 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT00783835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.