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

This study has been completed.
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
Prof. Dominique de Quervain, MD, University of Basel
ClinicalTrials.gov Identifier:
NCT01321021
First received: March 22, 2011
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention
Memory, Long-Term
Memory, Short-Term
Drug: Losartan, Diphenhydramine, Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects

Resource links provided by NLM:


Further study details as provided by University of Basel:

Primary Outcome Measures:
  • Primary Outcome Measures [ Time Frame: during cognitive testing at study days ] [ Designated as safety issue: No ]
    Memory functions


Secondary Outcome Measures:
  • Secondary Outcome Measures [ Time Frame: during cognitive testing at study days ] [ Designated as safety issue: No ]
    sleepiness, mood, anxiety, attention, fluid intelligence


Enrollment: 80
Study Start Date: March 2011
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Prof. Dominique de Quervain, MD, Prof., MD, University of Basel
ClinicalTrials.gov Identifier: NCT01321021     History of Changes
Other Study ID Numbers: 2011DR2032
Study First Received: March 22, 2011
Last Updated: May 2, 2012
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on July 20, 2014