Status:
COMPLETED
Study to Evaluate the Efficacy and Quality of Life of Long-Acting Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
Janssen-Cilag Farmaceutica Ltda.
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 H...
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 multip...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00783835
Start Date
February 1 2008
End Date
October 1 2008
Last Update
July 23 2013
Active Locations (5)
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1
Belo Horizonte, Brazil
2
Porto Alegre, Brazil
3
Rio de Janeiro, Brazil
4
Salvador, Brazil