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

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

Official Title
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Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder. A Randomised, Double-Blind, Placebo-Controlled Study

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: NS2359
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NS2359|nan|
|Drug: Placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the safety and tolerability of NS2359 in adult ADHD patients. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD