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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


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)


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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

Page last updated: August 20, 2015

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