Comparing the Effectiveness of New Versus Older Treatments for Attention Deficit Hyperactivity Disorder (The NOTA Study)

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine whether two new psychostimulant medications are more effective, tolerable, and acceptable than two older medications for treating attention deficit hyperactivity disorder.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Adderall; Amphetamine; Lisdexamfetamine Dimesylate; Methylphenidate

Criteria

Inclusion Criteria:

• Meets DSM-IV diagnostic criteria for ADHD combined, hyperactive/impulsive, or inattentive subtype

• Outpatient at study entry

• Speaks English

• Willing to be randomly assigned to one of the study treatment options as outlined in the protocol

• No known significant history of cardiovascular disorders, including pre-existing congenital heart disease, structural heart disease, known clinically significant electrocardiogram (ECG) abnormality, or other clinically significant cardiac disorder

• Willing to initiate study medication for ADHD within 7 days of the study baseline visit

• May be receiving stable treatment with other drug for a comorbid disorder, defined as no changes in dose or form of drug treatment for at least 2 weeks prior to the study enrollment visit

• May be receiving psychosocial interventions for ADHD or a comorbid disorder, defined as no changes in form of psychosocial treatment for at least 4 weeks prior to the study enrollment visit

Exclusion Criteria:

• Hypersensitivity to study medication

• Inpatient status at study entry

• Currently taking another medication for ADHD, including another psychostimulant, atomoxetine, or bupropion

• Receiving treatment with a tricyclic antidepressant at study enrollment, with the exception of low-dose imipramine for enuresis or amitriptyline for chronic pain

• Received treatment with a monoamine oxidase inhibitor (MAOI) within the past 30 days

• Psychostimulant drug dependence, bipolar disorder, or schizophrenia

• Presence of psychosis

• Severe mental retardation

• Autism or Asperger's syndrome

• Active suicidal ideation

• Unable or unwilling to comply with the protocol

• Demonstrates a lack of benefit from, an intolerance to, or contraindication to psychostimulant medicine

• Presence of other clinically significant medical conditions, including hyperthyroidism, epilepsy or other seizure disorder, any condition for which an increase in blood pressure or heart rate would be problematic, glaucoma or other significant eye disease for which a psychostimulant would be problematic, or pre-existing gastrointestinal obstruction with gastrointestinal narrowing

• Pregnant or positive result of pregnancy test