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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

329 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-28

Study Completion Date

2004-03-24

Brief Summary

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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).

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Detailed Description

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Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Adderall XR (10 mg)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Adderall XR (20 mg)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Adderall XR (30 mg)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Adderall XR (40 mg)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No