Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.

Overview

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.

Full Title of Study: “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).”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: November 4, 2005

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 Measures

  • 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
  • Brown ADD Scale (BADDS) – completed at Baseline and 6/ET visits
    • Time Frame: Baseline visit and weeks 1, 2, 3, 4, 5, & 6
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shire
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Takeda

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