Status:
COMPLETED
Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder
Lead Sponsor:
NeuroSearch A/S
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to investigate if NS2359 is effective in the treatment of ADHD in adult patients.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00467428
Start Date
August 1 2003
End Date
September 1 2004
Last Update
April 30 2007
Active Locations (1)
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1
Adult and Pediatric Psychopharmacology, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114