Clinical trial NCT00467428: Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder
Official title: Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder. A Randomised, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Lead sponsor: NeuroSearch A/S
Sponsor class: INDUSTRY
First posted: 2007-04-30
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: 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:
measure: To investigate the safety and tolerability of NS2359 in adult ADHD patients.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Adult and Pediatric Psychopharmacology, Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Adult and Pediatric Psychopharmacology, Masschusetts General Hospial, Boston, US
name: Thimothy Wilens, MD
role: PRINCIPAL_INVESTIGATOR
References: