Effects of H1-Antagonist on Cognition | RxWiki

Effects of H1-Antagonist on Cognition

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to determine whether histamine is involved in memory and specific processes in human cognition.
Condition	Cognition
Intervention	Drug: dexchlorpheniramine, lorazepam
Phase	N/A
Sponsor	Maastricht University Medical Center
Responsible Party	Maastricht University Medical Center
ClinicalTrials.gov Identifier	NCT00846950
First Received	February 17, 2009
Last Updated	February 18, 2009
Last verified	February 2009

Tracking Information[ + expand ][ + ]

First Received Date	February 17, 2009
Last Updated Date	February 18, 2009
Start Date	December 2006
Estimated Primary Completion Date	May 2007
Current Primary Outcome Measures	P300 latency and LRP onset latency [Time Frame: 1.5 hours after treatment] [Designated as safety issue: No]
Current Secondary Outcome Measures	Words recalled [Time Frame: 1.5 hours after treatment] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Effects of H1-Antagonist on Cognition
Official Title	Effects of H1-Antagonist on Stages of Human Information Processing
Brief Summary	The purpose of this study is to determine whether histamine is involved in memory and specific processes in human cognition.
Detailed Description	The neurotransmitter histamine appears to be involved in human cognitive performance. However, the exact role is very unclear. The role it plays in memory performance is highly disputed, as animal studies show decreased performance when the H1-receptor is blocked in the central nervous system while such findings in humans is scarce. To clarify the role of histamine in human memory and different processes in cognition, the effects of an H1-antagonist (dexchlorpheniramine) on memory, alertness and sensory and motor processes are measured. The study will be conducted according to a within subject cross-over design using healthy volunteers.
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Condition	Cognition
Intervention	Drug: dexchlorpheniramine, lorazepam
Study Arm (s)	Experimental: healthy volunteers

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	18
Estimated Completion Date	May 2007
Estimated Primary Completion Date	May 2007
Eligibility Criteria	Inclusion Criteria: - Healthy as determined by a physician Exclusion Criteria: - present or history of any neurological of psychiatric disease - present or history of any substance abuse
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Netherlands

Administrative Information[ + expand ][ + ]

NCT Number	NCT00846950
Other Study ID Numbers	06-3-075
Has Data Monitoring Committee	No
Information Provided By	Maastricht University Medical Center
Study Sponsor	Maastricht University Medical Center
Collaborators	Not Provided
Investigators	Principal Investigator: Annemiek Vermeeren, Ph.D. Maastricht University hospital
Verification Date	February 2009

Locations[ + expand ][ + ]