Clinical trial NCT00202605: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: PERMP (Permanent Product Measure of Performance)
timeFrame: 0.5 hours pre-dosing
measure: PERMP (Permanent Product Measure of Performance)
timeFrame: 2 hours post-dosing
measure: PERMP (Permanent Product Measure of Performance)
timeFrame: 4 hours post-dosing
measure: PERMP (Permanent Product Measure of Performance)
timeFrame: 8 hours post-dosing
measure: PERMP (Permanent Product Measure of Performance)
timeFrame: 12 hours post-dosing
measure: PERMP (Permanent Product Measure of Performance)
timeFrame: 14 hours post-dosing
measure: PERMP (Permanent Product Measure of Performance)
timeFrame: 16 hours post-dosing
Secondary outcomes:
measure: Time Segment Rating System (ADHD-RS[TSRS])
timeFrame: 5½, 11, and 16½ hours post-dosing
measure: Subject self report (ADHD-SRS) of ADHD
timeFrame: approximately 5½, 11, and 16½ hours post-dosing
measure: Treatment emergent adverse events
timeFrame: Throughout the study period of approximately 3.25 months.
measure: Modified Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Study orientation and randomization visit, Week 1 after Study orientation and randomization visit, Week 2 after Study orientation and randomization visit
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Clinical Study Center
state: Arkansas
city: Irvine
country: United States
facility: UCI Child Development Center
state: California
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Inc.
state: Nevada
city: Houston
country: United States
facility: Bayou City Research, Ltd.
state: Texas
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
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.