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

Not Applicable

Completed

• Conditions: Memory, Long-Term; Memory, Short-Term
• Interventions: Drug: Losartan, Diphenhydramine, Placebo

• Registration Number: NCT01321021
• Lead Sponsor: Prof. Dominique de Quervain, MD

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Primary Completion: 2011-07
• Study Completion: 2011-08
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-02
• Last Update Posted: 2012-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Losartan, Diphenhydramine, Placebo	Losartan, Diphenhydramine, Placebo	placebo controlled crossover study with two arms: Losartan, Diphenhydramine

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measures	during cognitive testing at study days	Memory functions

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome Measures	during cognitive testing at study days	sleepiness, mood, anxiety, attention, fluid intelligence

Trial Locations

Locations (1)

University of Basel, Division of Cognitive Neuroscience; 🇨🇭 Basel, Switzerland