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The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

A Phase 2, Randomized, Double-Blind, Multi-Center, Placebo- and Active-Controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder

NCT00928148•Shire

View on ClinicalTrials.gov

Summary

This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg) compared with placebo and an immediate release amphetamine salt formulation (25 mg) in adults with ADHD. The controlled environment used in this study is an analog classroom setting adapted for a 16-hour adult day.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult men and non-pregnant women between the ages of 18 and 55
•Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
•Baseline ADHD score of at least 24

Exclusion Criteria

•Weight less than 100 pounds or greater than 250 pounds
•Psychiatric diagnosis such as a severe comorbid Axis II or Axis I disorder
•Pregnancy or breastfeeding
•History of seizures
•Positive urine drug screen

Key Dates

Start Date

June 14, 2004

Primary Completion Date

November 20, 2004

Completion Date

November 20, 2004

Last Updated

June 3, 2021

Enrollment

ACTUAL participants

Conditions

Attention-Deficit/Hyperactivity Disorder

Interventions

SPD465

DRUG

Immediate Release Amphetamine Salt

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Inclusion Criteria

Exclusion Criteria

An Open-Label Treatment With Randomization Observation, Investigator-Initiated Study, on the Duration and Efficacy of Jornay PM (Methylphenidate Hydrochloride Extended-Release Capsules) on Adult ADHD Symptoms and Executive Function and Emotional Regulation Throughout the Day Into Early Evening

The ADHD Kids´ Study for Children 9-12 Years of Age

A Study to Assess the Effectiveness and Safety of Clonidine Extended-Release OnydaTM XR in Children With ADHD and ODD

Social Virtual-reality on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder

A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD