Efficacy and Safety of SPD465 in Adults With 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: NCT00150579
• Other study ID #: SPD465-301
• Status: Completed
• Phase: Phase 3
• Start date: January 27, 2005
• Est. completion date: June 14, 2005

Study information

• Verified date: June 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 sleep and how the participants perceive their quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 14, 2005
• Est. primary completion date: June 14, 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 >= 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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, 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	Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment.	The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.	Baseline, and the Endpoint (average of weeks 5, 6, 7).
Secondary	Change from Baseline in the Clinical Global Impression of Improvement scale (CGI-I) to the Endpoint assessment.	The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.	Baseline, and the Endpoint (average of weeks 5, 6, 7).
Secondary	Change from Baseline in the Time-Sensitive ADHD Symptom Scale (TASS) score to the Endpoint assessment.	The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.	Baseline, and the Endpoint (average of weeks 5, 6, 7).
Secondary	Change from Baseline in the Brown Attention Deficit Disorder Scale (BADDS) to the Endpoint assessment	The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.	Baseline, and the Endpoint (average of weeks 5, 6, 7).
Secondary	Change in Baseline in the Adult ADHD Impact Module (AIM-A) score to the Endpoint assessment	The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.	Baseline, and the Endpoint (average of weeks 5, 6, 7).
Secondary	Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 1		Baseline and Week 1.
Secondary	Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 4		Baseline and Week 4.
Secondary	Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 7		Baseline and Week 7.