NCT01321021CompletedNot Applicable
Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects
Prof. Dominique de Quervain, MD1 site in 1 country80 target enrollmentStarted: March 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Primary Outcome Measures
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
Losartan, Diphenhydramine, Placebo
Experimental
placebo controlled crossover study with two arms: Losartan, Diphenhydramine
Intervention: Losartan, Diphenhydramine, Placebo (Drug)
Outcomes
Primary Outcomes
Primary Outcome Measures
Time Frame: during cognitive testing at study days
Memory functions
Secondary Outcomes
- Secondary Outcome Measures(during cognitive testing at study days)
Investigators
Prof. Dominique de Quervain, MD
Prof., MD
University of Basel
Study Sites (1)
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