Back to resultsSafety and Efficacy of SPD465 in Adults With ADHD
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity
Eligibility Criteria
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
Sites / Locations
- Clinical Study Center
- UCI Child Development Center
- Center for Psychiatry and Behavioral Medicine, Inc.
- Bayou City Research, Ltd.
Outcomes
Primary Outcome Measures
PERMP (Permanent Product Measure of Performance)
PERMP (Permanent Product Measure of Performance)
PERMP (Permanent Product Measure of Performance)
PERMP (Permanent Product Measure of Performance)
PERMP (Permanent Product Measure of Performance)
PERMP (Permanent Product Measure of Performance)
PERMP (Permanent Product Measure of Performance)
Secondary Outcome Measures
Time Segment Rating System (ADHD-RS[TSRS])
Subject self report (ADHD-SRS) of ADHD
Treatment emergent adverse events
Modified Pittsburgh Sleep Quality Index (PSQI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00202605
Brief Title
Safety and Efficacy of SPD465 in Adults With ADHD
Official Title
A Phase II, Randomized, Double-Blind, Multi-center, Placebo-controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 29, 2005 (Actual)
Primary Completion Date
January 6, 2006 (Actual)
Study Completion Date
January 6, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
72 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate
Primary Outcome Measure Information:
Title
PERMP (Permanent Product Measure of Performance)
Time Frame
0.5 hours pre-dosing
Title
PERMP (Permanent Product Measure of Performance)
Time Frame
2 hours post-dosing
Title
PERMP (Permanent Product Measure of Performance)
Time Frame
4 hours post-dosing
Title
PERMP (Permanent Product Measure of Performance)
Time Frame
8 hours post-dosing
Title
PERMP (Permanent Product Measure of Performance)
Time Frame
12 hours post-dosing
Title
PERMP (Permanent Product Measure of Performance)
Time Frame
14 hours post-dosing
Title
PERMP (Permanent Product Measure of Performance)
Time Frame
16 hours post-dosing
Secondary Outcome Measure Information:
Title
Time Segment Rating System (ADHD-RS[TSRS])
Time Frame
5½, 11, and 16½ hours post-dosing
Title
Subject self report (ADHD-SRS) of ADHD
Time Frame
approximately 5½, 11, and 16½ hours post-dosing
Title
Treatment emergent adverse events
Time Frame
Throughout the study period of approximately 3.25 months.
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Study Center
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
UCI Child Development Center
City
Irvine
State/Province
California
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine, Inc.
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Bayou City Research, Ltd.
City
Houston
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29087231
Citation
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.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of SPD465 in Adults With ADHD
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