Influence of Losartan and Diphenhydramine on Emotional an... | NCT01321021

Studies
Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects

NCT01321021

Sponsor

Prof. Dominique de Quervain, MD

Status

Completed

Last Update Posted

May 3, 2012Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Memory, Long-Term
Memory, Short-Term

Interventions

Losartan, Diphenhydramine, Placebo

Countries

Switzerland

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

May 2012

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

Mar 2011

Primary Completion Date

Jul 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Mar 22, 2011

First Submission Date that Met QC Criteria

Mar 22, 2011

First Posted Date

Mar 23, 2011Estimated

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

May 2, 2012

Last Update Posted Date

May 3, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dominique de Quervain, MD, Prof., MD, University of BaselSponsor-Investigator

Lead Sponsor

Prof. Dominique de Quervain, MDOTHER

Collaborators

Name	Class
Clinical Trial Unit, University Hospital Basel, Switzerland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This project aims at identifying novel pharmacological targets for the treatment of memory disorders.

Detailed Description

To investigate the effects of the histamine H1 receptor antagonist diphenhydramine and the angiotensin II receptor antagonist losartan on emotional and cognitive functions in healthy human subjects.

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Losartan, Diphenhydramine, Placebo	Experimental	placebo controlled crossover study with two arms: Losartan, Diphenhydramine	Drug: Losartan, Diphenhydramine, Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Losartan, Diphenhydramine, Placebo	Drug	placebo controlled crossover study with two arms: Losartan 40mg, Diphenhydramine 40mg	Losartan, Diphenhydramine, Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Outcome Measures	Memory functions	during cognitive testing at study days

Secondary Outcomes

Measure	Description	Time Frame
Secondary Outcome Measures	sleepiness, mood, anxiety, attention, fluid intelligence	during cognitive testing at study days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy
native or fluent German-speaking
BMI between 19 and 27 kg/m2
able and willing to give written informed consent and comply with the requirements of the study protocol
willing to donate saliva sample for DNA-analysis
female: willing to perform a pregnancy test at the beginning of both test visits

Exclusion Criteria:

acute or chronic psychiatric or somatic disorder
pathological ECG
known hypersensitivity to the IMP under investigation (losartan, diphenhydramine)
hypotension (RR < 110/70 mmHg)
bradycardia (< 50 bpm)
pregnancy, breast-feeding
long-term medication within last 3 months (oral contraceptives are disregarded)
smoking (> 3 cigarettes per day)
concurrent participation in another study
participation in one of our previous studies using the same memory tests
inability to read and understand the participant's information

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dominique de Quervain, Prof. MD	University of Basel, Faculty of Psychology and Medecine, Division of Cognitive Neuroscience	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Basel, Division of Cognitive Neuroscience		Basel	Basel	4055	Switzerland

Intervention Browse Module

MeSH Terms

ID	Term
D019808	Losartan
D004155	Diphenhydramine

Ancestor Terms

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided