Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects
LoDi-Basel
1 other identifier
interventional
80
1 country
1
Brief Summary
This project aims at identifying novel pharmacological targets for the treatment of memory disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 22, 2011
CompletedFirst Posted
Study publicly available on registry
March 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedMay 3, 2012
May 1, 2012
4 months
March 22, 2011
May 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Outcome Measures
Memory functions
during cognitive testing at study days
Secondary Outcomes (1)
Secondary Outcome Measures
during cognitive testing at study days
Study Arms (1)
Losartan, Diphenhydramine, Placebo
EXPERIMENTALplacebo controlled crossover study with two arms: Losartan, Diphenhydramine
Interventions
placebo controlled crossover study with two arms: Losartan 40mg, Diphenhydramine 40mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Basel, Division of Cognitive Neuroscience
Basel, Basel, 4055, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dominique de Quervain, Prof. MD
University of Basel, Faculty of Psychology and Medecine, Division of Cognitive Neuroscience
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof., MD
Study Record Dates
First Submitted
March 22, 2011
First Posted
March 23, 2011
Study Start
March 1, 2011
Primary Completion
July 1, 2011
Study Completion
August 1, 2011
Last Updated
May 3, 2012
Record last verified: 2012-05