Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181675
Status:
COMPLETED
Last Update Posted:
2010-07-23
First Post:
2005-09-12
Brief Title:
A Double-Blind Comparison of Galantamine HBr and Placebo in Adults With Attention Deficit Hyperactivity Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Double-Blind Comparison of Galantamine HBr and Placebo in Adults With Attention Deficit Hyperactivity Disorder
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
Galantamine HBr a tertiary alkaloid is a competitive and reversible inhibitor of acetylcholinesterase that is indicated to slow the deterioration of cognitive impairment in Alzheimers 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None