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

NCT ID: NCT01321021

Last Updated: 2012-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-08-31

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.

Conditions

Memory, Long-Term; Memory, Short-Term

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Losartan, Diphenhydramine, Placebo

placebo controlled crossover study with two arms: Losartan, Diphenhydramine

Group Type: EXPERIMENTAL

Losartan, Diphenhydramine, Placebo

Intervention Type: DRUG

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

Interventions

Losartan, Diphenhydramine, Placebo

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinical Trial Unit, University Hospital Basel, Switzerland

OTHER

Sponsor Role: collaborator

Prof. Dominique de Quervain, MD

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dominique de Quervain, MD

Prof., MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dominique de Quervain, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University of Basel, Faculty of Psychology and Medecine, Division of Cognitive Neuroscience

Locations

University of Basel, Division of Cognitive Neuroscience

Basel, Basel, Switzerland

Countries

Switzerland

Other Identifiers

2011DR2032

Identifier Type: -

Identifier Source: org_study_id