Safety and Efficacy of SPD465 in Adults With ADHD

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202605
• Other study ID #: SPD465-203
• Status: Completed
• Phase: Phase 2
• Start date: September 29, 2005
• Est. completion date: January 6, 2006

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 6, 2006
• Est. primary completion date: January 6, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

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

Locations

Country	Name	City	State
United States	Bayou City Research, Ltd.	Houston	Texas
United States	UCI Child Development Center	Irvine	California
United States	Center for Psychiatry and Behavioral Medicine, Inc.	Las Vegas	Nevada
United States	Clinical Study Center	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PERMP (Permanent Product Measure of Performance)		0.5 hours pre-dosing
Primary	PERMP (Permanent Product Measure of Performance)		2 hours post-dosing
Primary	PERMP (Permanent Product Measure of Performance)		4 hours post-dosing
Primary	PERMP (Permanent Product Measure of Performance)		8 hours post-dosing
Primary	PERMP (Permanent Product Measure of Performance)		12 hours post-dosing
Primary	PERMP (Permanent Product Measure of Performance)		14 hours post-dosing
Primary	PERMP (Permanent Product Measure of Performance)		16 hours post-dosing
Secondary	Time Segment Rating System (ADHD-RS[TSRS])		5½, 11, and 16½ hours post-dosing
Secondary	Subject self report (ADHD-SRS) of ADHD		approximately 5½, 11, and 16½ hours post-dosing
Secondary	Treatment emergent adverse events		Throughout the study period of approximately 3.25 months.
Secondary	Modified Pittsburgh Sleep Quality Index (PSQI)		Study orientation and randomization visit, Week 1 after Study orientation and randomization visit, Week 2 after Study orientation and randomization visit