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

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

Study Overview

• Status: Completed
• Conditions: Memory, Short-Term; Memory, Long-Term
• Intervention / Treatment: Drug: Losartan, Diphenhydramine, Placebo

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
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4055
    • University of Basel, Division of Cognitive Neuroscience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measures	Memory functions	during cognitive testing at study days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome Measures	sleepiness, mood, anxiety, attention, fluid intelligence	during cognitive testing at study days

Collaborators and Investigators

• Sponsor: Prof. Dominique de Quervain, MD
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: March 22, 2011
• First Submitted That Met QC Criteria: March 22, 2011
• First Posted (Estimate): March 23, 2011

Study Record Updates

• Last Update Posted (Estimate): May 3, 2012
• Last Update Submitted That Met QC Criteria: May 2, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Hypnotics and Sedatives; Anesthetics, Local; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Diphenhydramine; Promethazine; Losartan
• Other Study ID Numbers: 2011DR2032