Safety and Efficacy of SPD465 in Adults With ADHD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-29

Study Completion Date

2006-01-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

NCT00928148

Attention-Deficit/Hyperactivity Disorder

COMPLETED PHASE2

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

NCT00152022

Attention Deficit Disorder With Hyperactivity

COMPLETED PHASE3

Efficacy and Safety of SPD465 in Adults With ADHD

NCT00150579

Attention Deficit Disorder With Hyperactivity

COMPLETED PHASE3

Safety of SPD465 in Treating Adults With ADHD.

NCT00152035

Attention Deficit Disorder With Hyperactivity

COMPLETED PHASE3

Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

NCT03260205

Attention Deficit Hyperactivity Disorder (ADHD)

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Disorder With Hyperactivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No