Safety and Efficacy of SPD465 in Adults With ADHD

A Phase II, Randomized, Double-Blind, Multi-center, Placebo-controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00202605

Enrollment

Registered

2005-09-20

Start date

2005-09-29

Completion date

2006-01-06

Last updated

2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder With Hyperactivity

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.

Interventions

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
PERMP (Permanent Product Measure of Performance)	0.5 hours pre-dosing

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026