NCT00846950

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

Enrollment Period

5 months

First QC Date

February 17, 2009

Last Update Submit

February 18, 2009

Conditions

Cognition

Keywords

H1-antagonistEvent Related PotentialsMemoryInformation processingThe effects of an H1 antagonist (dexchlorpheniramine) on human cognition

Outcome Measures

Primary Outcomes (1)

  • P300 latency and LRP onset latency

    1.5 hours after treatment

Secondary Outcomes (1)

  • Words recalled

    1.5 hours after treatment

Study Arms (1)

healthy volunteers

EXPERIMENTAL
Drug: dexchlorpheniramine, lorazepam

Interventions

dexchlorpheniramine, lorazepamDRUG
healthy volunteers

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy as determined by a physician

You may not qualify if:

  • present or history of any neurological of psychiatric disease
  • present or history of any substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Psychology and Neuroscience, Maastricht University

Maastricht, Limburg, 6229 ER, Netherlands

Location

MeSH Terms

Interventions

dexchlorpheniramineLorazepam

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Annemiek Vermeeren, Ph.D.

    Maastricht University hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 19, 2009

Study Start

December 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

February 19, 2009

Record last verified: 2009-02

Locations

NL(1)