Effects of H1-Antagonist on Cognition | NCT00846950

Studies
Effects of H1-Antagonist on Cognition

NCT00846950

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Feb 19, 2009Estimated

Enrollment

18Actual

Phase

Not Applicable

Conditions

Cognition

Interventions

dexchlorpheniramine, lorazepam

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Feb 17, 2009

First Submission Date that Met QC Criteria

Feb 18, 2009

First Posted Date

Feb 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2009

Last Update Posted Date

Feb 19, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Label	Type	Description	Intervention Names
healthy volunteers	Experimental		Drug: dexchlorpheniramine, lorazepam

Name	Type	Description	Arm Group Labels	Other Names
dexchlorpheniramine, lorazepam	Drug		healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
P300 latency and LRP onset latency		1.5 hours after treatment

Secondary Outcomes

Measure	Description	Time Frame
Words recalled		1.5 hours after treatment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annemiek Vermeeren, Ph.D.	Maastricht University hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Psychology and Neuroscience, Maastricht University		Maastricht	Limburg	6229 ER	Netherlands

Intervention Browse Module

MeSH Terms

ID	Term
C018904	dexchlorpheniramine
D008140	Lorazepam

Ancestor Terms

ID	Term
D001570	Benzodiazepinones
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided