Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.

A Phase III, Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00152022

Enrollment

412

Registered

2005-09-09

Start date

2005-04-25

Completion date

2005-11-04

Last updated

2021-07-13

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 this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects the participants sleep and how they perceive their quality of life.

Interventions

DRUGNeutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Primary diagnosis of ADHD * Baseline ADHD-RS-IV score \>= 32 * Non-pregnant females of childbearing potential must comply with contraceptive restrictions.

Exclusion criteria

* Significantly underweight or morbidly obese * Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders * History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder * Females who are pregnant or lactating

Design outcomes

Primary

Measure	Time frame	Description
The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)	Baseline (following ADHD medication washout of 7-28 days)	The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.

Secondary

Measure	Time frame
Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET)	Weeks 1, 2, 3, 4, 5, & 6
Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits	Baseline visit and weeks 1, 2, 3, 4, 5, & 6
Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits.	Baseline visit and weeks 1, 2, 3, 4, 5, & 6
Pittsburgh Sleep Quality Index (PSQI) - taken at every visit from Baseline to study completion.	Baseline visit and weeks 1, 2, 3, 4, 5, & 6

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026