A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall

NCT00468143 | Completed Phase 4 Results

• 1 other identifier: IR v XR
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to compare Adderall ® and Adderall XR ® in terms of their effectiveness and side effects for the treatment of ADHD in adults.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (3)

• Medication Event Monitoring System (MEMS®) Dosage Adherence

  Dosage adherence (MEMSd) is the number of bottle openings divided by number of doses prescribed. Adherence was measured as ≥ 75% of the doses. The number below is the total percentage of subjects who were adherent.

  The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)

• Medication Event Monitoring System (MEMS®) Regimen Adherence

  Regimen adherence (MEMSr) is a percentage of the number of days in which the complete dose regimen was taken as prescribed. Adherence was measured as complete dose regimen taken on ≥ 90% of days. The number below is the total percentage of subjects who were adherent.

  The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)

• Medication Event Monitoring System (MEMS®) Time Adherence

  Time adherence (MEMSt) is the percentage of doses taken as prescribed within a specified time period. Adherence was measured as ≥ 80% of doses taken at the correct time. The number below is the percentage of subjects who were adherent.

  The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)

Secondary Outcomes (2)

• Pill Count

  At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)

• Self Report

  At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)

Study Arms (2)

Adderall Extended Release First

EXPERIMENTAL

This group was treated with Adderall extended release, either during phase 2 of the trial, or during phase 3 (this subset received Adderall immediate release during phase 2 and then underwent a washout period). This was a counterbalanced crossover study, with a washout period in between treatment periods. Participants were randomized in a 1:1 ratio to one of two schedules Adderall IR followed by Adderall XR, or Adderall XR followed by Adderall IR.

Drug: Adderall ® Immediate Release; Drug: Adderall XR ®

Adderall Immediate Release First

EXPERIMENTAL

This group was treated with Adderall immediate release, either during phase 2 of the trial, or during phase 3 (this subset received Adderall extended release during phase 2 and then underwent a washout period). This was a counterbalanced crossover study, with a washout period in between treatment periods. Participants were randomized in a 1:1 ratio to one of two schedules Adderall IR followed by Adderall XR, or Adderall XR followed by Adderall IR.

Drug: Adderall ® Immediate Release; Drug: Adderall XR ®

Interventions

Adderall ® Immediate Release DRUG

Adderall Immediate release (IR) was provided as treatment for three weeks (at 15, 30 or 45 mg TID). The medication was optimized for titration.

Adderall Extended Release First; Adderall Immediate Release First

Adderall XR ® DRUG

Adderall Extended Release (XR) was provided as treatment for three weeks at (15, 30, or 45 mg QD). The medication was optimized for titration.

Also known as: extended release adderall

Adderall Extended Release First; Adderall Immediate Release First

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• At the time of consent, are between the ages of 18-55, inclusive.
• Meet DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS) v1.2.
• Female participants of childbearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control during the study. Females of childbearing potential are defined as women not surgically sterilized and are between menarche and 2 years post-menopause.
• Must have a satisfactory medical assessment with no clinically significant abnormalities as determined by medical history, physical exam, ECG, and clinical laboratory testing.
• Must be able to swallow capsules.
• Must be able to begin the daily dose of study medication in the morning.
• Must be off previous amphetamine or methylphenidate treatment for 1 week prior to baseline (visit 2). Must be off past non-stimulant ADHD medication (i.e., atomoxetine) for 3 weeks prior to baseline (visit 2).
• In the opinion of the investigator, the subject must understand and be able, willing and likely to fully comply with the study procedures and restrictions.
• Must have given signed and dated informed consent in accordance with Good Clinical Practice (GCP) Guidelines.

You may not qualify if:

• Lifetime or present history of bipolar disorder, schizophrenia or schizoaffective disorder.
• Uncontrolled comorbid major depressive disorder, anxiety disorder or dysthymia. Participants with controlled depressive or anxiety disorders may participate if their medications have been stabilized for a minimum of four weeks and, in the opinion of the Principal Investigator, will not interfere with adherence, safety, or efficacy assessments.
• Anyone who meets current DSM-IV-TR criteria for alcohol or any non-alcohol substance abuse or dependence disorder (excluding nicotine).
• Have organic brain disease (such as dementia) or traumatic brain injury residua. Have a history of seizure disorder (other than febrile seizures) or participants who have taken (or are currently taking) anticonvulsants for seizure control.
• Females who are currently pregnant or breast feeding, and women of child-bearing potential who are not currently using an adequate form of birth control.
• Participants who work the night shift or another schedule that would preclude beginning the daily dose of study medication in the morning.
• Participants with a positive urine drug result at Screening.
• Participants with any concurrent chronic or acute illness or unstable medical condition that could, in the opinion of the study physician, confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol. Subjects who have a history of mental retardation or severe learning disability will be excluded.
• Participants with a history of structural cardiac abnormalities as well as any other condition that may affect cardiac performance.
• Participants with documented history of allergy, intolerance, or non-responsivity to methylphenidate or amphetamines. This includes a history of two or more failed stimulant treatment trials, as deemed by the Principal Investigator.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

VANYHHS

New York, New York, 10010, United States

Location

Related Publications (1)

• Adler LA, Lynch LR, Shaw DM, Wallace SP, Ciranni MA, Briggie AM, Kulaga A, O'Donnell KE, Faraone SV. Medication adherence and symptom reduction in adults treated with mixed amphetamine salts in a randomized crossover study. Postgrad Med. 2011 Sep;123(5):71-9. doi: 10.3810/pgm.2011.09.2461.

  PMID: 21904088 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Adderall; SLI381

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Lenard Adler
• Organization: NYU School of Medicine

lenard.adler@nyumc.org

(212) 263-3580

Study Officials

• Lenard Adler, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2007
• First Posted: May 2, 2007
• Study Start: August 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: June 2, 2016
• Results First Posted: June 2, 2016

Record last verified: 2016-04

Locations

US (1)