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

NCT00889915 | Completed Phase 4 Results DMC

• 3 other identifiers: Pro00014075P30MH066386-02DSIR CTM 4571; Pro00014075
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD; Methylphenidate; Amphetamine

Outcome Measures

Primary Outcomes (1)

• Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale

  The CGI-E is the value at which the participant's Therapeutic Benefit and Adverse Impact to the study drug intersect. This number is determined by combining each participant's scores for the degree of Therapeutic Benefit versus the degree to which problems with Tolerability and/or Acceptability adversely impact the subject. Participants are then determined to be Responders or Non-responders to the study medication. For example, a subject who is very much improved (CGI-I=1) or much improved (CGI-I=2) therapeutically and whose adverse impact rating is none (score 1,5) or mild (score 2,6) will be categorized as a Responder. All others whose adverse impact rating is moderate (score 3,7,11,15)or outweighs therapeutic effect (score 4,8,12,16) will be categorized as Non-responders to study medication. The CGI scores are totaled for each participant and a mean score is calculated. A median total score was calculated for each treatment group.

  Measured at each participant's last visit, which can occur at or before Week 6

Secondary Outcomes (2)

• Clinical Global Impressions-Improvement (CGI-I) Scale

  Measured at each participant's last visit, which can occur at or before Week 6

• Clinical Global Improvements-Acceptability (CGI-A) Scale

  Measured at each participant's last visit, which can occur at or before Week 6

Study Arms (4)

1

ACTIVE COMPARATOR

Participants will receive methylphenidate transdermal system.

Drug: Methylphenidate transdermal system

2

ACTIVE COMPARATOR

Participants will receive lisdexamfetamine dimesylate.

Drug: Lisdexamfetamine dimesylate

3

ACTIVE COMPARATOR

Participants will receive osmotic-release oral system methylphenidate (OROS MPH).

Drug: Osmotic-release oral system methylphenidate (OROS MPH)

4

ACTIVE COMPARATOR

Participants will receive mixed amphetamine salts extended release.

Drug: Mixed amphetamine salts extended release

Interventions

Methylphenidate transdermal system DRUG

Not specified in protocol; determined by local standard of care.

Also known as: Daytrana

1

Lisdexamfetamine dimesylate DRUG

Not specified in protocol; determined by local standard of care.

Also known as: Vyvanse

2

Osmotic-release oral system methylphenidate (OROS MPH) DRUG

Not specified in protocol; determined by local standard of care.

Also known as: Concerta

3

Mixed amphetamine salts extended release DRUG

Not specified in protocol; determined by local standard of care.

Also known as: Adderall XR

4

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Child and Adolescent Psychiatry Trials Network (CAPTN)

Durham, North Carolina, 27710, United States

Location

Related Links

• Click here for the Duke Clinical Research Institute Web site
• Click here for the American Academy of Child and Adolescent Psychiatry Web site

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; Lisdexamfetamine Dimesylate; SLI381

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines

Results Point of Contact

• Title: John S. March, MD, MPH
• Organization: Duke Clinical Research Institute - Duke University School of Medicine

john.march@duke.edu

919-668-7818

Study Officials

• John S. March, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 29, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 30, 2013
• Results First Posted: September 30, 2013

Record last verified: 2013-07

Locations

US (1)