Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ADHD
Brief summary
The purpose of the study is to investigate if NS2359 is effective in the treatment of ADHD in adult patients.
Interventions
DRUGNS2359
DRUGPlacebo
Sponsors
NeuroSearch A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview using the K-SADS-E adult ADHD module * Patients with a CGI Global Severity (GS) score ≥4 (moderate impairment) * The Patient provided written informed consent. * Non-lactating women of childbearing potential that used adequate contraception (i.e. the use of oral contraceptives and practising a double-barrier form of birth control) and had a negative pregnancy test at screening. Women of no childbearing potential who had been postmenopausal for less than 2 years must have a negative pregnancy test at screening.
Exclusion criteria
* Any clinically unstable medical condition * Clinically significant abnormal baseline laboratory values * Mental retardation * Organic brain disorders * Non-febrile seizure disorder * Patients with a history of an eating disorder including anorexia or bulimia nervosa * Psychotic disorder of any type * Patients with a HAM-D (17 item) \>15 * Patients currently (within the past 6 months) known to abuse or to be dependent on any drug, including alcohol or a positive urine drug screen for cocaine, heroin, or marijuana * Treatment with stimulants was prohibited within 1 week prior to randomisation * Treatment with antipsychotics/neuroleptics was prohibited for 8 weeks prior to randomisation * Treatment with monoamine oxidase inhibitors was prohibited for 8 weeks prior to randomisation * Treatment with tricyclic antidepressants, histamines and selective serotonin reuptake inhibitors was prohibited for 4 weeks (fluoxetine for 6 weeks) prior to randomisation * Treatment with benzodiazepines, anticonvulsants (for behaviour) and lithium for 2 weeks prior to randomisation * Patients with a history of bipolar disorder * Patients using any concurrent medication for the treatment of ADHD * Patients that had previously participated in a NS2359 study * Patients treated with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication * Patients with a history of positive human immunodeficiency virus (HIV) test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the efficacy of NS2359 in adult patients diagnosed with ADHD (predominantly inattentive, predominantly hyperactive/impulsive or combined) according to DSM-IV criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the safety and tolerability of NS2359 in adult ADHD patients. | — |
Countries
United States
Outcome results
None listed