CompletedNCT00202605Updated Jun 24, 2021

Safety and Efficacy of SPD465 in Adults With ADHD

A Phase 2 interventional study of Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate in Attention Deficit Disorder With Hyperactivity, sponsored by Shire. Completed at 4 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-06-24.

Sponsored by Shire · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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.

Conditions studied

Attention Deficit Disorder With Hyperactivity

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In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 72 is close to the median of 80 across 583 interventional studies indexed under Hyperkinesis.

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Lead sponsor

Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double
Enrollment: 72 participants

Interventions

DrugNeutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate

What researchers measure

Primary outcomes

PERMP (Permanent Product Measure of Performance)
Time frame: 0.5 hours pre-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 2 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 4 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 8 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 12 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 14 hours post-dosing
PERMP (Permanent Product Measure of Performance)
Time frame: 16 hours post-dosing

Secondary outcomes

Time Segment Rating System (ADHD-RS[TSRS])
Time frame: 5½, 11, and 16½ hours post-dosing
Subject self report (ADHD-SRS) of ADHD
Time frame: approximately 5½, 11, and 16½ hours post-dosing
Treatment emergent adverse events
Time frame: Throughout the study period of approximately 3.25 months.
Modified Pittsburgh Sleep Quality Index (PSQI)
Time frame: Study orientation and randomization visit, Week 1 after Study orientation and randomization visit, Week 2 after Study orientation and randomization visit

Study locations

4 sites

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

References and documents

Publications

Wigal T, Childress A, Frick G, Yan B, Wigal S, Madhoo M. Effects of SHP465 mixed amphetamine salts in adults with ADHD in a simulated adult workplace environment. Postgrad Med. 2018 Jan;130(1):111-121. doi: 10.1080/00325481.2018.1389227. Epub 2017 Oct 31. PubMed 29087231 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00202605
Lead sponsor: Shire
Responsible party: Sponsor
First posted: Sep 20, 2005
Start date: Sep 29, 2005
Primary completion: Jan 6, 2006
Completion: Jan 6, 2006
Last update: Jun 24, 2021

Study contacts

Study Director

study director · Takeda

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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