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

NCT00152022 | Completed Phase 3

• 1 other identifier: SPD465-303
• Study Type: interventional
• Target: 412
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (7)

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

  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.

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

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

  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.

  Week 1

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

  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.

  Week 2

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

  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.

  Week 3

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

  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.

  Week 4

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

  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.

  Week 5

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

  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.

  Week 6

Secondary Outcomes (4)

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

  Weeks 1, 2, 3, 4, 5, & 6

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

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

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

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

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

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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary diagnosis of ADHD
• Baseline ADHD-RS-IV score \>= 32
• Non-pregnant females of childbearing potential must comply with contraceptive restrictions.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shire: lead

Related Publications (2)

• Surman CB, Roth T. Impact of stimulant pharmacotherapy on sleep quality: post hoc analyses of 2 large, double-blind, randomized, placebo-controlled trials. J Clin Psychiatry. 2011 Jul;72(7):903-8. doi: 10.4088/JCP.11m06838.

  PMID: 21824454 DERIVED

• Brown TE, Landgraf JM. Improvements in executive function correlate with enhanced performance and functioning and health-related quality of life: evidence from 2 large, double-blind, randomized, placebo-controlled trials in ADHD. Postgrad Med. 2010 Sep;122(5):42-51. doi: 10.3810/pgm.2010.09.2200.

  PMID: 20861587 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Amphetamine; Fumigant 93

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: April 25, 2005
• Primary Completion: November 4, 2005
• Study Completion: November 4, 2005
• Last Updated: July 13, 2021

Record last verified: 2021-07