Clinical Trial: Safety and Efficacy of SPD465 in Adults with ADHD

This study is not yet open for patient recruitment.
Verified by Shire Pharmaceutical Development September 2005

Sponsored by: Shire Pharmaceutical Development
Information provided by: Shire Pharmaceutical Development
ClinicalTrials.gov Identifier: NCT00202605

Purpose

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 Intervention 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 II

MedlinePlus related topics:  Attention Deficit Disorder with Hyperactivity

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Official Title: A Phase II, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Crossover Study of SPD465 in Adults with Attention-Deficit Hyperactivity Disorder (ADHD)

Further Study Details: 
Primary Outcomes: PERMP (Permanent Product Measure of Performance) at 7 time points
Secondary Outcomes: Time Segment Rating System (ADHD-RS[TSRS]); Subject self report (ADHD-SRS) of ADHD; Treatment emergent adverse events; Modified Pittsburgh Sleep Quality Index (PSQI)
Expected Total Enrollment:  72

Study start: September 2005

Eligibility

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00202605


California
      UCI Child Development Center, Irvine,  California,  United States
Amanda Shanklin  949-824-3667 
Tim Wigal, PhD,  Principal Investigator

Nevada
      Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas,  Nevada,  United States
Heidi Valja  702-838-0742 
Ann Childress, MD,  Principal Investigator

Texas
      Bayou City Research, Ltd., Houston,  Texas,  United States
Kathy Harpst  832-251-7000 
Matthew Brams, MD,  Principal Investigator

More Information

Study ID Numbers:  SPD465-203
Last Updated:  September 19, 2005
Record first received:  September 12, 2005
ClinicalTrials.gov Identifier:  NCT00202605
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-20

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