Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)

Shire

Status and phase: Completed; Phase 3

Conditions: ADHD

Treatments: Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00507065

SLI381-314A

Details and patient eligibility

About

Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (<= 75 kg or > 75 kg).

Enrollment: 329 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males/females 13-17 years of age meeting DSM-IV criteria for a primary diagnosis of ADHD

Exclusion criteria

• Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD
• Known non-responder to stimulant medication
• Documented allergy or intolerance to ADDERALL, ADDERALL XR or amphetamines
• Conduct Disorder, hypertension, history of seizure
• Tic disorder or Tourette's disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

329 participants in 5 patient groups, including a placebo group

Adderall XR (10 mg)

Experimental group

Treatment:

Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)

Adderall XR (20 mg)

Experimental group

Treatment:

Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)

Adderall XR (30 mg)

Experimental group

Treatment:

Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)

Adderall XR (40 mg)

Experimental group

Treatment:

Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)

placebo

Placebo Comparator group

Treatment:

Drug: Placebo