Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder

NCT ID: NCT00467428

Last Updated: 2007-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2004-09-30

Brief Summary

The purpose of the study is to investigate if NS2359 is effective in the treatment of ADHD in adult patients.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

NS2359

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuroSearch A/S

INDUSTRY

Sponsor Role: lead

Principal Investigators

Thimothy Wilens, MD

Role: PRINCIPAL_INVESTIGATOR

Adult and Pediatric Psychopharmacology, Masschusetts General Hospial, Boston, US

Locations

Adult and Pediatric Psychopharmacology, Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

NS2359-001

Identifier Type: -

Identifier Source: org_study_id