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

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ClinicalTrials.gov Identifier: NCT01321021
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : May 3, 2012
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
Prof. Dominique de Quervain, MD, University of Basel

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

Condition or disease Intervention/treatment Phase
Memory, Long-Term Memory, Short-Term Drug: Losartan, Diphenhydramine, Placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects
Study Start Date : March 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011


Arm Intervention/treatment
Experimental: Losartan, Diphenhydramine, Placebo
placebo controlled crossover study with two arms: Losartan, Diphenhydramine
Drug: Losartan, Diphenhydramine, Placebo
placebo controlled crossover study with two arms: Losartan 40mg, Diphenhydramine 40mg




Primary Outcome Measures :
  1. Primary Outcome Measures [ Time Frame: during cognitive testing at study days ]
    Memory functions


Secondary Outcome Measures :
  1. Secondary Outcome Measures [ Time Frame: during cognitive testing at study days ]
    sleepiness, mood, anxiety, attention, fluid intelligence



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321021


Locations
Switzerland
University of Basel, Division of Cognitive Neuroscience
Basel, Switzerland, 4055
Sponsors and Collaborators
Prof. Dominique de Quervain, MD
Clinical Trial Unit, University Hospital Basel, Switzerland
Investigators
Principal Investigator: Dominique de Quervain, Prof. MD University of Basel, Faculty of Psychology and Medecine, Division of Cognitive Neuroscience

Responsible Party: Prof. Dominique de Quervain, MD, Prof., MD, University of Basel
ClinicalTrials.gov Identifier: NCT01321021     History of Changes
Other Study ID Numbers: 2011DR2032
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: May 3, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Losartan
Diphenhydramine
Promethazine
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Hypnotics and Sedatives
Anti-Allergic Agents
Antipruritics
Dermatologic Agents