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OpenTrials
Completed

NCT Number: NCT00152022

Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic 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 the participants sleep and how they 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 >= 32
  • 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
  • Females who are pregnant or lactating

Treatment and study plan

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

Drug

Primary outcomes

  1. The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)

    Time frame: Baseline (following ADHD medication washout of 7-28 days)

    The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.

  2. The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)

    Time frame: Week 1

    The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.

  3. The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)

    Time frame: Week 2

    The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.

  4. The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)

    Time frame: Week 3

    The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.

  5. The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)

    Time frame: Week 4

    The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.

  6. The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)

    Time frame: Week 5

    The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.

  7. The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)

    Time frame: Week 6

    The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.

Secondary outcomes

  1. Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET)

    Time frame: Weeks 1, 2, 3, 4, 5, & 6

  2. Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits

    Time frame: Baseline visit and weeks 1, 2, 3, 4, 5, & 6

  3. Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits.

    Time frame: Baseline visit and weeks 1, 2, 3, 4, 5, & 6

  4. Pittsburgh Sleep Quality Index (PSQI) - taken at every visit from Baseline to study completion.

    Time frame: Baseline visit and weeks 1, 2, 3, 4, 5, & 6

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 9, 2005
Registry last updated
Jul 13, 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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