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OpenTrials
Completed

NCT Number: NCT01321021

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

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

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Key information

Conditions

Memory, Long-Term Memory, Short-Term

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Basel, Division of Cognitive Neuroscience

Basel, 4055, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Losartan, Diphenhydramine, Placebo

Drug

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

Primary outcomes

  1. Primary Outcome Measures

    Time frame: during cognitive testing at study days

    Memory functions

Secondary outcomes

  1. Secondary Outcome Measures

    Time frame: during cognitive testing at study days

    sleepiness, mood, anxiety, attention, fluid intelligence

Sponsors and collaborators

Lead sponsor

Prof. Dominique de Quervain, MD

Other

Collaborators

  • Clinical Trial Unit, University Hospital Basel, Switzerland

Registry information

Acronym: LoDi-Basel

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 23, 2011
Registry last updated
May 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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