Effects of Lisdexamfetamine Dimesylate on the Functioning of College Students With Attention-deficit/Hyperactivity Disorder (ADHD)
This study has been completed.
Sponsor:
University of Rhode Island
Collaborator:
Lehigh University
Information provided by:
University of Rhode Island
ClinicalTrials.gov Identifier:
NCT01342445
First received: April 21, 2011
Last updated: April 26, 2011
Last verified: April 2011
| Tracking Information | |||||
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| First Received Date ICMJE | April 21, 2011 | ||||
| Last Updated Date | April 26, 2011 | ||||
| Start Date ICMJE | September 2009 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Conners Adult ADHD Rating Scale [ Time Frame: Participants will complete this measure once per week for the five consecutive weeks that they are enrolled in the study ] [ Designated as safety issue: No ] Adult self-report measure of ADHD symptoms |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01342445 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Lisdexamfetamine Dimesylate on the Functioning of College Students With Attention-deficit/Hyperactivity Disorder (ADHD) | ||||
| Official Title ICMJE | Effects of Vyvanse on the Behavioral, Academic, and Psychosocial Functioning of College Students With ADHD | ||||
| Brief Summary | The purpose of this study is to evaluate the effects of lisdexamfetamine dimesylate, a prodrug stimulant, on the behavioral, academic, and psychosocial functioning of college students with attention-deficit/hyperactivity disorder (ADHD). Twenty-five college students with ADHD from two universities (University of Rhode Island and Lehigh University) will complete a within-subject, placebo-controlled research trial. Dependent measures tapping behavioral, psychosocial, and academic functioning will be completed on a weekly basis across five conditions (baseline, placebo, and 30-mg, 50-mg, and 70-mg lisdexamfetamine). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Attention-deficit/Hyperactivity Disorder | ||||
| Intervention ICMJE | Drug: lisdexamfetamine dimesylate
30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design
Other Name: Vyvanse |
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| Study Arm (s) | Experimental: lisdexamfetamine dimesylate
All participants will be assessed across five conditions (baseline, placebo, 30-mg, 50-mg, & 70-mg) in a double-blind, crossover design
Intervention: Drug: lisdexamfetamine dimesylate |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 24 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 28 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01342445 | ||||
| Other Study ID Numbers ICMJE | Shire-80000311112 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Lisa L. Weyandt, Ph.D., Professor of Psychology, University of Rhode Island | ||||
| Study Sponsor ICMJE | University of Rhode Island | ||||
| Collaborators ICMJE | Lehigh University | ||||
| Investigators ICMJE |
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| Information Provided By | University of Rhode Island | ||||
| Verification Date | April 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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