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

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00152022
• Collaborator: (none)
• Enrollment: 412
• Actual Duration (Months): 6.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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).
• Actual Study Start Date: Apr 25, 2005
• Actual Primary Completion Date: Nov 4, 2005
• Actual Study Completion Date: Nov 4, 2005

Outcome Measures

Primary Outcome Measures

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

1. Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET) [Weeks 1, 2, 3, 4, 5, & 6]

2. Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits [Baseline visit and weeks 1, 2, 3, 4, 5, & 6]

3. Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits. [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. [Baseline visit and weeks 1, 2, 3, 4, 5, & 6]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT00152022
• Other Study ID Numbers: SPD465-303
• First Posted: Sep 9, 2005
• Last Update Posted: Jul 13, 2021
• Last Verified: Jul 1, 2021

• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Amphetamine; Dextroamphetamine; Adderall

Study Results

No Results Posted as of Jul 13, 2021