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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00846950
Other study ID # 06-3-075
Secondary ID
Status Completed
Phase N/A
First received February 17, 2009
Last updated February 18, 2009
Start date December 2006
Est. completion date May 2007

Study information

Verified date February 2009
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether histamine is involved in memory and specific processes in human cognition.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
dexchlorpheniramine, lorazepam


Locations

Country Name City State
Netherlands Faculty of Psychology and Neuroscience, Maastricht University Maastricht Limburg

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary P300 latency and LRP onset latency 1.5 hours after treatment No
Secondary Words recalled 1.5 hours after treatment No
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