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

Memory, Short-Term Clinical Trial

— LoDi-Basel  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321021
• Other study ID #: 2011DR2032
• Status: Completed
• Phase: N/A
• First received: March 22, 2011
• Last updated: May 2, 2012
• Start date: March 2011
• Est. completion date: August 2011

Study information

• Verified date: May 2012
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Memory, Long-Term
• Memory, Short-Term

Intervention

Drug:
• Losartan, Diphenhydramine, Placebo
placebo controlled crossover study with two arms: Losartan 40mg, Diphenhydramine 40mg

Locations

Country	Name	City	State
Switzerland	University of Basel, Division of Cognitive Neuroscience	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dominique de Quervain, MD	Clinical Trial Unit, University Hospital Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measures	Memory functions	during cognitive testing at study days	No
Secondary	Secondary Outcome Measures	sleepiness, mood, anxiety, attention, fluid intelligence	during cognitive testing at study days	No