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

NCT00467428 | Completed Phase 2

• 1 other identifier: NS2359-001
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Interventions

NS2359 DRUG

Placebo DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuroSearch A/S: lead

Study Sites (1)

Adult and Pediatric Psychopharmacology, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

GSK372475

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Thimothy Wilens, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: April 30, 2007
• Study Start: August 1, 2003
• Study Completion: September 1, 2004
• Last Updated: April 30, 2007

Record last verified: 2007-04

Locations

US (1)