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Safety of SPD465 in Treating Adults With ADHD.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00152035
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : January 16, 2017
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Brief Summary:
The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.

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, l-amphetamine aspartate monohydrate. Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1040 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Multi-center, 12-month, Open-label Safety Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).
Study Start Date : March 2005
Actual Study Completion Date : May 2007

Primary Outcome Measures :
  1. The evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination.

Secondary Outcome Measures :
  1. ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter.
  2. Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET).
  3. Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject satisfied all entry criteria for the antecedent protocol (SPD465-301 or SPD465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events.
  • Subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods.

Exclusion Criteria:

  • Subject was terminated from antecedent protocol (SPD465-301 or SPD465-303) for non-compliance and/or experienced a serious adverse event or adverse event resulting in termination from the protocol.
  • Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Asix I disorders.
  • History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
  • Females who are pregnant of lactating.

Layout table for additonal information Identifier: NCT00152035     History of Changes
Other Study ID Numbers: SPD465-304
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors