Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder - Full Text View

Sponsored by:	NeuroSearch A/S
Information provided by:	NeuroSearch A/S
ClinicalTrials.gov Identifier:	NCT00467428

Purpose

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

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: NS2359 Drug: Placebo	Phase II

Drug Information available for: NS 2359

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder. A Randomised, Double-Blind, Placebo-Controlled Study

Further study details as provided by NeuroSearch A/S:

Primary Outcome Measures:

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:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467428

Locations

United States, Massachusetts
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

More Information

No publications provided

Study ID Numbers:	NS2359-001
Study First Received:	April 27, 2007
Last Updated:	April 27, 2007
ClinicalTrials.gov Identifier:	NCT00467428 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NeuroSearch A/S:

ADHD

Study placed in the following topic categories:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Signs and Symptoms
Pathologic Processes
Disease
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Nervous System Diseases

Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

ClinicalTrials.gov processed this record on May 07, 2009