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Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects (LoDi-Basel)

P

Prof. Dominique de Quervain, MD

Status

Completed

Conditions

Memory, Long-Term
Memory, Short-Term

Treatments

Drug: Losartan, Diphenhydramine, Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01321021
2011DR2032

Details and patient eligibility

About

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

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

80 participants in 1 patient group

Losartan, Diphenhydramine, Placebo
Experimental group
Description:
placebo controlled crossover study with two arms: Losartan, Diphenhydramine
Treatment:
Drug: Losartan, Diphenhydramine, Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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