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Safety and Efficacy of SPD465 in Adults With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00202605
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 6, 2007
Sponsor:
Information provided by:
Shire

Brief Summary:
The purpose of the study is to evaluate how safe and how well SPD465 works compared to placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration of clinical benefit.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Study Start Date : September 2005
Actual Study Completion Date : April 2006





Primary Outcome Measures :
  1. PERMP (Permanent Product Measure of Performance) at 7 time points

Secondary Outcome Measures :
  1. Time Segment Rating System (ADHD-RS[TSRS])
  2. Subject self report (ADHD-SRS) of ADHD
  3. Treatment emergent adverse events
  4. Modified Pittsburgh Sleep Quality Index (PSQI)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis of ADHD using DSM-IV-TR criteria (at least 6 of the 9 subtype criteria met)
  • Baseline ADHD-RS-IV score =>24
  • IQ score of => 80 (using Kaufman Brief Intelligence Test)

Exclusion Criteria:

  • BMI < 18.5 or > 30 kg/m2
  • Diagnosis of Post Traumatic Stress Disorder, psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
  • History of seizure disorder or a lifetime history of any seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
  • History of uncontrolled hypertension or currently hypertensive
  • Subjects who have taken atomoxetine (STRATTERA) within 30 days prior to screening
  • Current (or history within the last 12 months) of drug dependence or substance abuse disorder according to DSM-IV-TR criteria (excluding nicotine)
  • Female subject is pregnant or lactating, less than 3 months post partum

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202605


Locations
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United States, Arkansas
Clinical Study Center
Little Rock, Arkansas, United States
United States, California
UCI Child Development Center
Irvine, California, United States
United States, Nevada
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States
United States, Texas
Bayou City Research, Ltd.
Houston, Texas, United States
Sponsors and Collaborators
Shire

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00202605     History of Changes
Other Study ID Numbers: SPD465-203
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 6, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
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Amphetamine
Dextroamphetamine
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors