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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152022
• Other study ID #: SPD465-303
• Status: Completed
• Phase: Phase 3
• Start date: April 25, 2005
• Est. completion date: November 4, 2005

Study information

• Verified date: July 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: November 4, 2005
• Est. primary completion date: November 4, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET)		Weeks 1, 2, 3, 4, 5, & 6
Secondary	Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits		Baseline visit and weeks 1, 2, 3, 4, 5, & 6
Secondary	Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits.		Baseline visit and weeks 1, 2, 3, 4, 5, & 6
Secondary	Pittsburgh Sleep Quality Index (PSQI) - taken at every visit from Baseline to study completion.		Baseline visit and weeks 1, 2, 3, 4, 5, & 6