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

This study has been completed.
Sponsor:
Information provided by:
NeuroSearch A/S
ClinicalTrials.gov Identifier:
NCT00467428
First received: April 27, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder. A Randomised, Double-Blind, Placebo-Controlled Study

Resource links provided by NLM:


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:
  • To investigate the safety and tolerability of NS2359 in adult ADHD patients.

Enrollment: 126
Study Start Date: August 2003
Study Completion Date: September 2004
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by NeuroSearch A/S:
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014