Safety and Efficacy of SPD465 in Adults With ADHD

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00202605
• Collaborator: (none)
• Enrollment: 72
• Locations: 4
• Actual Duration (Months): 3.3
• Patients Per Site: 18
• Patients Per Site Per Month: 5.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Phase II, Randomized, Double-Blind, Multi-center, Placebo-controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
• Actual Study Start Date: Sep 29, 2005
• Actual Primary Completion Date: Jan 6, 2006
• Actual Study Completion Date: Jan 6, 2006

Outcome Measures

Primary Outcome Measures

1. PERMP (Permanent Product Measure of Performance) [0.5 hours pre-dosing]

2. PERMP (Permanent Product Measure of Performance) [2 hours post-dosing]

3. PERMP (Permanent Product Measure of Performance) [4 hours post-dosing]

4. PERMP (Permanent Product Measure of Performance) [8 hours post-dosing]

5. PERMP (Permanent Product Measure of Performance) [12 hours post-dosing]

6. PERMP (Permanent Product Measure of Performance) [14 hours post-dosing]

7. PERMP (Permanent Product Measure of Performance) [16 hours post-dosing]

Secondary Outcome Measures

1. Time Segment Rating System (ADHD-RS[TSRS]) [5½, 11, and 16½ hours post-dosing]

2. Subject self report (ADHD-SRS) of ADHD [approximately 5½, 11, and 16½ hours post-dosing]

3. Treatment emergent adverse events [Throughout the study period of approximately 3.25 months.]

4. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT00202605
• Other Study ID Numbers: SPD465-203
• First Posted: Sep 20, 2005
• Last Update Posted: Jun 24, 2021
• Last Verified: Jun 1, 2021

• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Amphetamine; Dextroamphetamine

Study Results

No Results Posted as of Jun 24, 2021