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OpenTrials
Completed

NCT Number: NCT00150579

Efficacy and Safety of SPD465 in Adults With ADHD

The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects sleep and how the participants perceive their quality of life.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary diagnosis of ADHD
  • Baseline ADHD-RS-IV score >= 24
  • Non-pregnant females of childbearing potential must comply with contraceptive restrictions

Exclusion criteria

  • Significantly underweight or morbidly obese
  • Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders
  • History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder

Treatment and study plan

Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate

Drug

Primary outcomes

  1. Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment.

    Time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).

    The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.

Secondary outcomes

  1. Change from Baseline in the Clinical Global Impression of Improvement scale (CGI-I) to the Endpoint assessment.

    Time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).

    The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.

  2. Change from Baseline in the Time-Sensitive ADHD Symptom Scale (TASS) score to the Endpoint assessment.

    Time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).

    The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.

  3. Change from Baseline in the Brown Attention Deficit Disorder Scale (BADDS) to the Endpoint assessment

    Time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).

    The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.

  4. Change in Baseline in the Adult ADHD Impact Module (AIM-A) score to the Endpoint assessment

    Time frame: Baseline, and the Endpoint (average of weeks 5, 6, 7).

    The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.

  5. Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 1

    Time frame: Baseline and Week 1.

  6. Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 4

    Time frame: Baseline and Week 4.

  7. Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 7

    Time frame: Baseline and Week 7.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Phase III, Randomized, Double-blind, Multi-center, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 8, 2005
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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