- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00846950
Effects of H1-Antagonist on Cognition
February 18, 2009 updated by: Maastricht University Medical Center
Effects of H1-Antagonist on Stages of Human Information Processing
The purpose of this study is to determine whether histamine is involved in memory and specific processes in human cognition.
Study Overview
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
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
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Maastricht, Limburg, Netherlands, 6229 ER
- Faculty of Psychology and Neuroscience, Maastricht University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: healthy volunteers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
P300 latency and LRP onset latency
Time Frame: 1.5 hours after treatment
|
1.5 hours after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Words recalled
Time Frame: 1.5 hours after treatment
|
1.5 hours after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Annemiek Vermeeren, Ph.D., Maastricht University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
February 17, 2009
First Submitted That Met QC Criteria
February 18, 2009
First Posted (Estimate)
February 19, 2009
Study Record Updates
Last Update Posted (Estimate)
February 19, 2009
Last Update Submitted That Met QC Criteria
February 18, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Lorazepam
- Dexchlorpheniramine
Other Study ID Numbers
- 06-3-075
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.