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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

NS2359

Placebo

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Adult and Pediatric Psychopharmacology, Massachusetts General Hospital

Outcomes

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.

Full Information

NCT ID

NCT00467428

First Posted

April 27, 2007

Last Updated

April 27, 2007

Sponsor

NeuroSearch A/S

1. Study Identification

Unique Protocol Identification Number

NCT00467428

Brief Title

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

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Completed

Study Start Date

August 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

NeuroSearch A/S

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

Keywords

ADHD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

NS2359

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thimothy Wilens, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Adult and Pediatric Psychopharmacology, Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

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

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