Safety and Efficacy of SPD465 in Adults With ADHD
Information source: Shire
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Disorder With Hyperactivity
Intervention: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Shire
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: PERMP (Permanent Product Measure of Performance) at 7 time points
Secondary outcome: Time Segment Rating System (ADHD-RS[TSRS])Subject self report (ADHD-SRS) of ADHD Treatment emergent adverse events Modified Pittsburgh Sleep Quality Index (PSQI)
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): 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
Locations and Contacts
Clinical Study Center, Little Rock, Arkansas, United States
UCI Child Development Center, Irvine, California, United States
Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, Nevada, United States
Bayou City Research, Ltd., Houston, Texas, United States
Additional Information
Starting date: September 2005
Last updated: November 2, 2007
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