Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Shire

Status and phase: Completed; Phase 1

Conditions: Attention-Deficit Hyperactivity Disorder

Treatments: Drug: Lisdexamfetamine Dimesylate (LDX); Drug: LDX Placebo + MAS-IR Placebo; Drug: Immediate Release Mixed Amphetamine Salts (MAS-IR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01010750

SPD489-115

Details and patient eligibility

About

To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based, battery of neuro-psychometric tests in adults with ADHD.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD (diagnostic code 314.00 and 314.01) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria with at least 6 of the 9 subtype criteria met.
2. Subject has been previously treated for ADHD with an adequate course of amphetamine therapy with no history of intolerance, or lack of efficacy, as determined by the Investigator.
3. Subject does not have any physical disability (eg. colorblindness, limitations with use of one or both hands, etc) that would interfere with the subject's participation in or performance on any of the neuropsychometric tests. For a number of these tasks speed is a key factor thus subjects cannot have any obvious impediments/impairments in the use of their hands.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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18 participants in 3 patient groups, including a placebo group

LDX + MAS-IR Placebo

Active Comparator group

Description:

Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo

Treatment:

Drug: Lisdexamfetamine Dimesylate (LDX)

MAS-IR + LDX Placebo

Active Comparator group

Description:

Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo

Treatment:

Drug: Immediate Release Mixed Amphetamine Salts (MAS-IR)

Placebo

Placebo Comparator group

Description:

Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo

Treatment:

Drug: LDX Placebo + MAS-IR Placebo