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Completed

NCT Number: NCT00202605

Safety and Efficacy of SPD465 in Adults With ADHD

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Study Center, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

  1. PERMP (Permanent Product Measure of Performance)

    Time frame: 0.5 hours pre-dosing

  2. PERMP (Permanent Product Measure of Performance)

    Time frame: 2 hours post-dosing

  3. PERMP (Permanent Product Measure of Performance)

    Time frame: 4 hours post-dosing

  4. PERMP (Permanent Product Measure of Performance)

    Time frame: 8 hours post-dosing

  5. PERMP (Permanent Product Measure of Performance)

    Time frame: 12 hours post-dosing

  6. PERMP (Permanent Product Measure of Performance)

    Time frame: 14 hours post-dosing

  7. PERMP (Permanent Product Measure of Performance)

    Time frame: 16 hours post-dosing

Secondary outcomes

  1. Time Segment Rating System (ADHD-RS[TSRS])

    Time frame: 5½, 11, and 16½ hours post-dosing

  2. Subject self report (ADHD-SRS) of ADHD

    Time frame: approximately 5½, 11, and 16½ hours post-dosing

  3. Treatment emergent adverse events

    Time frame: Throughout the study period of approximately 3.25 months.

  4. 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

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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