A Double-Blind Comparison of Galantamine HBr and Placebo in Adults With Attention Deficit Hyperactivity Disorder
|First Received Date ICMJE||September 12, 2005|
|Last Updated Date||July 22, 2010|
|Start Date ICMJE||December 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||symptom reduction using ADHD- Clinical Global Impression & ADHD Symptom Checklist Severity Scale administered weekly|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00181675 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Double-Blind Comparison of Galantamine HBr and Placebo in Adults With Attention Deficit Hyperactivity Disorder|
|Official Title ICMJE||A Double-Blind Comparison of Galantamine HBr and Placebo in Adults With Attention Deficit Hyperactivity Disorder|
This will be a double-blind, placebo-controlled, study using daily doses of up to 24 mg/ day Galantamine HBr in the treatment of adults who meet DSM-IV criteria for childhood-onset ADHD. Specific hypotheses are as follows:
Hypothesis 1: ADHD symptomatology in adults with DSM-IV ADHD will be responsive to acute Galantamine HBr treatment.
Hypothesis 2: Galantamine HBr -associated improvement in ADHD symptomatology in adults will translate into improved functional capacities (neuropsychological, social, and occupational) as well as an increased quality of life throughout acute treatment.
Hypothesis 3: Galantamine HBr treatment will be safe and well tolerated as reflected by a low drop out rate and absence of major differences from placebo.
Galantamine HBr, a tertiary alkaloid, is a competitive and reversible inhibitor of acetylcholinesterase that is indicated to slow the deterioration of cognitive impairment in Alzheimer's Disease. Initial anecdotal data suggest a promising role for Galantamine HBr in the treatment of ADHD. We propose to study to test the safety and efficacy of Galantamine HBr therapy in adults with ADHD. We will test if Galantamine HBr -associated improvements in ADHD symptomatology translate into improved cognitive and functional capacities (social and occupational) as well as increased quality of life.
The proposed study includes 1) use of a 12-week design to document the response rate 2) assessment of the impact of Galantamine HBr on functional capacities (quality of life, psychosocial function) and cognition, 3) careful assessment of safety and tolerability.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Intervention ICMJE||Drug: galantamine HBr|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||September 2003|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 58 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00181675|
|Other Study ID Numbers ICMJE||2002-P-001937|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Joseph Biederman, MD, Massachusetts General Hospital|
|Study Sponsor ICMJE||Massachusetts General Hospital|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Massachusetts General Hospital|
|Verification Date||July 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP