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Efficacy and Safety of SPD465 in Adults With ADHD

Sponsor
Shire (Industry)
Overall Status
Completed
CT.gov ID
NCT00150579
Collaborator
(none)
240
Enrollment
4.5
Actual Duration (Months)

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 sleep and how the participants perceive their quality of life.

Condition or Disease Intervention/Treatment Phase
  • Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, 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 :
Jan 27, 2005
Actual Primary Completion Date :
Jun 14, 2005
Actual Study Completion Date :
Jun 14, 2005

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment. [Baseline, and the Endpoint (average of weeks 5, 6, 7).]

    The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.

Secondary Outcome Measures

  1. Change from Baseline in the Clinical Global Impression of Improvement scale (CGI-I) to the Endpoint assessment. [Baseline, and the Endpoint (average of weeks 5, 6, 7).]

    The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.

  2. Change from Baseline in the Time-Sensitive ADHD Symptom Scale (TASS) score to the Endpoint assessment. [Baseline, and the Endpoint (average of weeks 5, 6, 7).]

    The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.

  3. Change from Baseline in the Brown Attention Deficit Disorder Scale (BADDS) to the Endpoint assessment [Baseline, and the Endpoint (average of weeks 5, 6, 7).]

    The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.

  4. Change in Baseline in the Adult ADHD Impact Module (AIM-A) score to the Endpoint assessment [Baseline, and the Endpoint (average of weeks 5, 6, 7).]

    The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.

  5. Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 1 [Baseline and Week 1.]

  6. Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 4 [Baseline and Week 4.]

  7. Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 7 [Baseline and Week 7.]

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 >= 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

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:
NCT00150579
Other Study ID Numbers:
  • SPD465-301
First Posted:
Sep 8, 2005
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Amphetamine
Dextroamphetamine
Adderall

Study Results

No Results Posted as of Jun 30, 2021