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

This study has been completed.
Sponsor:
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00152022
First received: September 7, 2005
Last updated: November 2, 2007
Last verified: November 2007
History of Changes
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

Primary Outcome Measures:
  • The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) taken at the Baseline visit and all visits thereafter.

Secondary Outcome Measures:
  • Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET)
  • Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits
  • Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits.
  • Pittsburgh Sleep Quality Index (PSQI) - taken at every visit from Baseline to study completion.

Estimated Enrollment: 412
Study Start Date: April 2005
Study Completion Date: April 2006
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided by Shire Development LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00152022     History of Changes
Other Study ID Numbers: SPD465-303
Study First Received: September 7, 2005
Last Updated: November 2, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Amphetamine
Methamphetamine
Dextroamphetamine
Adderall
Central Nervous System Stimulants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013