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

• Sponsor: NeuroSearch A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00467428
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 9.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Drug: NS2359; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder. A Randomised, Double-Blind, Placebo-Controlled Study
• Study Start Date: Aug 1, 2003
• Actual Study Completion Date: Sep 1, 2004

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. To investigate the safety and tolerability of NS2359 in adult ADHD patients. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adult and Pediatric Psychopharmacology, Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• NeuroSearch A/S

Investigators

• Principal Investigator: Thimothy Wilens, MD, Adult and Pediatric Psychopharmacology, Masschusetts General Hospial, Boston, US

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00467428
• Other Study ID Numbers: NS2359-001
• First Posted: Apr 30, 2007
• Last Update Posted: Apr 30, 2007
• Last Verified: Apr 1, 2007

• Keywords provided by , ,: ADHD
• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Apr 30, 2007